The effect of prophylactic clipping for colorectal cold snare polypectomy (CSP) on delayed bleeding (DB) in patients with antithrombotic drugs remains unverified. The aim of the PERCOLD study is to demonstrate the non-inferiority of DB rates in cases without prophylactic clips compared with cases with prophylactic clips in patients taking antithrombotic drugs for colorectal CSP through randomised controlled trial (RCT).

This study is a multicentre prospective parallel-group RCT phase 3 trial that is being conducted at 14 institutions in Japan at the time of writing this manuscript. After providing consent, patients will undergo screening and assessment for study enrolment eligibility. Patients taking antithrombotic drugs (aged 20 years or older at the time of consent and who have agreed to participate in this study) will be selected if they have a preoperative suspected adenoma (including sessile serrated lesion) with an endoscopic diameter of

The trial protocol has been approved by the Chiba University Certified Clinical Research Reviewer Board (CRB3180015), which serves as the central ethics committee, and registered with Japan Registry of Clinical Trials. The current protocol V.1.7, dated 4 October 2024. Written informed consent for participation in the study will be obtained from all participating patients. All participating institutions have formally agreed to conduct the study in accordance with this central approval, and local site permissions were obtained as required by each institution. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.

Japan Registry of Clinical Trials (jRCT1032230086).

Colonoscopy is an essential procedure for the early diagnosis of colorectal conditions; however, over 60% of patients undergoing non-sedated colonoscopy report moderate to severe pain. This study aims to investigate the central analgesic mechanisms of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA). A multimodal approach combining electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to assess pain-related brain activity, with artificial intelligence applied to model the relationship between objective neurophysiological signals and subjective pain experience.

This is a single-centre, randomised, double-blind, controlled trial involving 60 patients undergoing colonoscopy without anaesthesia. Participants will be randomly allocated (1:1) to either an electrical stimulation group receiving TENS-WAA or a sham stimulation group. EEG and fNIRS data will be acquired before, during and after the procedure. The primary outcome is the analysis of EEG-fNIRS signals to characterise cerebral responses associated with pain modulation. Secondary outcomes include patient-reported pain using the Visual Analogue Scale (VAS), total colonoscopy duration and the correlation between EEG-fNIRS indicators and VAS scores. A deep learning framework will be used to enhance pain prediction accuracy.

This study has received ethical approval from the Ethics Committee of Changhai Hospital, Shanghai (approval reference CHEC2025-006), and has been registered at ClinicalTrials.gov. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed academic journals and at relevant scientific conferences, regardless of outcome, contributing to evidence-based, non-pharmacological pain management strategies.

ClinicalTrials.gov, NCT06813703.

Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.

The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.

We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.

The study findings will provide the evidence base to inform future colorectal diagnostic services.

The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.

ISRCTN16126290.

The functional cure of chronic hepatitis B (CHB) is an ideal goal of therapy, as it is associated with improved long-term outcomes. Patients with low levels of HBsAg have higher rates of functional cure by pegylated interferon α (PEG-IFNα) therapy, and similar results have been observed in patients treated with PD-1 antibody. However, the combination therapy of PD-1 antibody and PEG-IFNα for promoting functional cure has not been studied. This study protocol aims to evaluate the efficacy and safety of a novel combined strategy, PD-1 antibody combined with PEG-IFNα therapy, in nucleos(t)ide analogues (NAs)-treated CHB patients.

This is a prospective, multicentre, open-label, randomised controlled study. Virologically suppressed CHB patients by NAs therapy will be recruited and randomised into PEG-IFNα group, PD-1 antibody group or PD-1 antibody combined PEG-IFNα group. PD-1 antibody will be injected intravenously once per 3 weeks for 24 weeks, and PEG-IFNα will be injected subcutaneously once a week for 48 weeks. The primary outcomes are the rate of HBsAg loss at 24 weeks. For safety analysis, adverse events in different groups will be compared.

This study has been approved by the Ethics Committee of the Fifth Medical Center of the Chinese PLA General Hospital (KY-2023-12-86-3). All results of the study will be submitted to a peer-reviewed journal.

NCT06357806.

Structured Early detection of Asymptomatic Liver fibrosis and cirrhosis (SEAL) is a population-based screening programme using non-invasive tests for the early detection of liver fibrosis. This study evaluates the cost implications if the SEAL programme were to be implemented in routine care in Germany.

This study models cost differences with and without the SEAL screening programme. We regress costs of care on patient characteristics (age, comorbidities, sex, liver diseases, liver cancer and liver fibrosis and cirrhosis (LCI) stage) using statutory health insurance (SHI) data from routine care patients with LCI (n=4177). Based on these results, we predict per-patient costs for the patients newly diagnosed with LCI by SEAL (n=45). Costs with and without screening are estimated using patient age and LCI stage distributions from either SEAL or routine care.

SEAL was conducted in two German states. Initial screening was performed by patients’ primary care physicians.

Individuals insured by SHI without a prior diagnosis of LCI, eligible for Check-up 35, a general health check-up programme primarily targeting adults aged 35 and older, conducted by primary care physicians.

Screening via aspartate aminotransferase to platelet ratio index in primary care, for further evaluation serological diagnostics and ultrasound examinations in secondary care and specific assessment for definite diagnosis including transient elastography and liver biopsy for selected cases in tertiary care.

Primary outcome measures: expected 5-year cost changes for SEAL patients diagnosed with fibrosis or cirrhosis compared to costs without a screening programme. Secondary outcome measures: case mix of leading chronic liver disease and LCI stages among patients diagnosed with advanced fibrosis or cirrhosis in SEAL versus routine care without screening.

Screening leads to fewer decompensated cases at initial diagnosis (4.6% in SEAL vs 22.8% in routine care) and thus savings in the costs of care within the first years of diagnosis: total expected costs per case were 2175 lower (bias-corrected bootstrap CIs (BCI): 527 to 3734), and LCI-associated costs were reduced by 1218 (BCI: 296 to 2164). Comparing the savings to the additional costs of diagnosis (range: 1575–1726 per detected LCI case) reveals that average changes in costs with screening range from moderate savings to moderate extra costs.

SEAL liver screening identifies patients in less advanced stages of LCI. If only costs were considered that are directly attributable to LCI, savings within 5 years are unlikely to fully outweigh the costs of screening. However, since this approach might miss additional LCI-related costs, SEAL appears to be cost-neutral compared with routine care when considering total healthcare costs.

The SEAL registration number is DRKS00013460. This study relates to its results.

Although a number of preclinical studies have demonstrated the therapeutic potential of puerarin for metabolic-associated fatty liver disease (MAFLD), there is a lack of high-quality clinical evidence. This study aims to evaluate the safety and efficacy of puerarin in patients with MAFLD in a randomised, controlled, crossover trial.

This study will use the randomised, double-blind, placebo-controlled crossover trial design. We plan to enrol 50 patients diagnosed with MAFLD, and they will be randomly assigned in a 1:1 ratio to receive either puerarin or placebo (maltodextrin) after a 2-week adaptation period. Participants in the two groups will receive the daily intervention of puerarin (180 mg/day) and placebo (180 mg/day) for 12 weeks, respectively. After a 4-week washout period, puerarin-treated and placebo-treated participants will cross over to receive the daily intervention of placebo and puerarin for 12 more weeks. The primary outcome measure will be defined as the changes in liver fat content, which will be assessed using MRI-proton density fat fraction before and after 12 weeks of puerarin or placebo supplement in patients with MAFLD. The secondary outcome measures include liver and kidney function changes, lipid metabolism indicators, blood glucose levels, iron metabolism parameters, blood routine, serum high-sensitivity C-reactive protein and anthropometric measurements. Additionally, alterations in gut microbiota composition and metabolic activity will be evaluated using 16S ribosomal RNA gene sequencing and liquid chromatography-mass spectrometry.

The study protocol has been approved by the ethics committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Approval Number 2024-1625-208-01). The findings will be published in international peer-reviewed journals and presented at relevant academic conferences.

The trial has been registered with the Chinese Clinical Trial Registry (ChiCTR2400094017).

Despite advances in diagnostics, many patients with gastric cancer (GC) or oesophagogastric junction cancer present with advanced disease, most commonly peritoneal metastasis (PM), which conveys a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) and anti-programmed cell death protein-1 (PD-1) therapy have each shown promise in GC. We describe the protocol for a study evaluating the efficacy and safety of combining HIPEC with the anti-PD-1 antibody tislelizumab and SOX (oxaliplatin+S-1) chemotherapy in patients with GC/oesophagogastric junction cancer and PM.

This is a multicentre, single-arm, phase II trial conducted at 13 high-volume tertiary referral hospitals across China. We will enrol 50 adults (18–75 years) with histologically confirmed GC/oesophagogastric junction adenocarcinoma and PM diagnosed by laparoscopy. Participants will receive one laparoscopy-guided HIPEC cycle (paclitaxel, total dose: 175 mg/m², 3000 mL of physiological saline at 43°C for 60 min, inflow rate 1.5 L/min, 10 min physiological saline preconditioning at 41°C) followed—after a 3-week interval—by up to three 3-week cycles of tislelizumab 200 mg plus SOX (oxaliplatin 130 mg/m² and S-1 dose-escalated by body surface area). HER2-positive patients will also receive trastuzumab. Primary endpoint: 1-year overall survival. Secondary endpoints: 1-year progression-free survival, completeness of Cytoreduction Score and objective response rate. Follow-up includes imaging and toxicity assessments every 3 months for at least 1 year.

The protocol was approved by the Ethics Committee of The First Affiliated Hospital of Nanjing Medical University (ID 2024-SR-198). All participants will provide written informed consent. Results will be disseminated via peer-reviewed publications; de-identified individual participant data will be available from the corresponding author on reasonable request after publication.

ClinicalTrials.gov, NCT06427252

Colonoscopy is often associated with significant patient pain and anxiety. Virtual reality (VR) technology has been widely used to alleviate pain and anxiety in patients undergoing invasive surgeries. However, there is a lack of reliable evidence supporting its effectiveness in reducing pain and anxiety in patients undergoing colonoscopy. We aim to conduct a meta-analysis to investigate the effectiveness of VR in alleviating pain and anxiety in patients undergoing colonoscopy.

We will search PubMed, EMBASE, Web of Science and the Cochrane Library from inception to August 2024 for randomised controlled trials evaluating VR interventions for patients undergoing colonoscopy, without language restrictions. Two reviewers will independently screen studies, extract data and assess the risk of bias using the Cochrane Risk of Bias tool. The primary outcomes will be patient-reported pain and anxiety. A meta-analysis will be performed using RevMan V.5.4, with subgroup and meta-regression analyses to explore potential heterogeneity. The certainty of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.

This systematic review does not require ethical approval, given that it will not directly utilize information from human participants—instead, the data to be used will be extracted from original studies. Additionally, this systematic review and meta-analysis has been registered with the International Prospective Register of Systematic Reviews (PROSPERO). Following the completion of the systematic review and meta-analysis, we intend to publish the study in an academic journal.

CRD42024580998.

To explore the challenges faced by young and middle-aged patients with Crohn’s disease (CD) in managing home enteral nutrition (HEN) and to identify strategies to improve their self-management and treatment adherence.

A qualitative phenomenological study.

The study was conducted at a comprehensive tertiary hospital in Jiangsu, China, with a focus on patients undergoing long-term HEN treatment for CD.

14 participants, aged 18–60 years, diagnosed with CD, and receiving HEN. Inclusion criteria required participants to be capable of clear self-expression and to provide voluntary consent. Exclusion criteria included cognitive impairment, mental illness or other major health conditions unrelated to CD.

Data were collected through semistructured interviews, exploring participants’ self-management challenges with HEN.

14 valid interviews were included for analysis. Two main themes were identified: subjective challenges, including psychological burden, self-management confidence and disease perception bias, and objective challenges, including social restrictions, economic burden and insufficient support systems.

Young and middle-aged patients with CD face significant subjective and objective challenges in managing HEN, which impact their physical and psychological well-being. Targeted interventions are needed to address these difficulties and improve self-management support.

The global burden of chronic immune-mediated inflammatory diseases (IMIDs) is increasing, and rising prevalence rates significantly affect socioeconomic factors and quality of life. Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), along with ankylosing spondylitis (AS), are prominent chronic IMIDs that share overlapping pathophysiological mechanisms. Recent research has highlighted the importance of the gut microbiota in the pathogenesis of these diseases, suggesting that shared microbial dysbiosis may contribute to their development. Comprehensive research focusing on the gut and oral microbial characteristics and environmental factors is essential to elucidate the fundamental pathophysiology and develop personalised management strategies for IBD and AS. In-depth analyses and insights based on multiomics approaches are required to achieve these objectives.

This protocol describes a nationwide prospective observational study of CD, UC and AS in a Korean population. Over 5 years, we aim to recruit at least 900 patients with IBD and 200 first-degree relatives (FDRs), 500 patients with AS and 200 of their FDRs, and 2244 healthy controls. We will systematically collect clinical data and biological samples, including saliva, stool, blood and tissue biopsies, for integrative multiomics analyses focusing primarily on the microbiome. Highly advanced full-length 16S ribosomal RNA gene sequencing and shotgun metagenomics will be used to characterise the microbial composition of saliva and stool samples. Quantitative microbiome profiling will be used to address the pathological, physiological and ecological differences between microbial groups that may be masked by their relative abundance. Metabolomic analyses will be conducted on saliva, stool and plasma samples to assess functional metabolic profiles. Culturomics will be used to isolate, identify and characterise the diversity of microbial species, including rare or previously unrecognised species, to provide a comprehensive understanding of the microbiota associated with these diseases.

Ethical approval was obtained from the Ethics Committee of Kyung Hee University Hospital, Hanyang University Hospital, Kangbuk Samsung Hospital, Yeungnam University Hospital, Kyungpook National University Hospital, Chonnam National University Hospital, Wonkwang University Hospital, Catholic University Daejeon St. Mary’s Hospital, Soon Chun Hyang University Hospital Cheonan, Chung-Ang University Hospital, Inje University Haeundae Paik Hospital, Dankook University Hospital, Hanyang University Guri Hospital, Kyung Hee University Hospital at Gangdong, Chung-Ang University Gwangmyeong Hospital and Keimyung University Dongsan Hospital. Our research team will provide detailed information about the study, including an information sheet explaining its aims and procedures, prior to enrolment. Prospective participants will be informed that they have the right to withdraw from the study at any time, without penalty. Participants will be assured of the anonymity and confidentiality of any data they provide throughout the study, using participant numbers and the storage of sensitive data in locked cabinets. Participants will be enrolled in the study only after providing written informed consent to the research staff. The results of this study will be disseminated to healthcare and academic professionals through publications in peer-reviewed journals and presentations at international conferences.

This prospective observational study is registered at ClinicalTrials.gov ((ID: NCT06124833, data first posted: 9 November 2023); (ID: NCT06076083, data first posted: 21 November 2023) and (ID: NCT06183697, data first posted: 27 December 2023)).

Traditional colorectal cancer (CRC) screening programmes in China face two major challenges: low screening coverage and poor adherence. Mobile health shows promise for cancer prevention, and a WeChat-based intelligent tool has been developed to support full-cycle CRC screening, including risk assessment, individualised screening recommendation, appointment management, result processing and health education. This study aims to evaluate the feasibility and effectiveness of this tool-based screening strategy in a multicentre, prospective cohort.

10 000 eligible participants aged 45–74 years will be enrolled from five provinces in China. After signing informed consent, participants need to complete an online questionnaire based on the modified and widely validated Asia-Pacific Colorectal Screening score. A score of ≥4 indicates high risk; otherwise, participants are classified as low or intermediate risk. For high-risk individuals, colonoscopy is recommended as the primary screening method, with faecal immunochemical test (FIT) as an alternative. For those at low or intermediate risk, FIT is recommended, followed by diagnostic colonoscopy for those who test positive. The primary outcomes are the detection rate of advanced colorectal neoplasia, compliance rates and detection rate of any colorectal adenoma at baseline screening. Final diagnoses are based on colonoscopy and pathology results. The secondary outcomes include CRC incidence and mortality, which will be assessed through passive follow-up over at least 10 years using linkage to cancer registry and death surveillance databases.

The programme was approved by the Ethics Committee of the National Cancer Center/Cancer Hospital, the Chinese Academy of Medical Sciences and Peking Union Medical College (23/220-3962). Expected outcomes will be disseminated through research reports, peer-reviewed papers, conference and patents.

ChiCTR2400086754.

Recurrence of hypertriglyceridaemia-associated acute pancreatitis (HTG-AP) is common. Uncontrolled HTG after hospital discharge is an important risk factor for recurrence. However, the optimal triglyceride (TG) goal of lipid-lowering therapy for outpatients remains unclear. The efficacy and safety of intensive TG-lowering therapy on reducing recurrence of HTG-AP trial aims to determine whether intensive TG-lowering therapy (with a TG goal of

This is an investigator-initiated, multicentre, open-label, parallel, superiority, randomised, controlled trial. Adult patients who have been successfully treated and discharged from their index episode of HTG-AP will be screened for eligibility after a 4-week to 3-month run-in period in the outpatient setting, and then patients with the fasting serum TG levels ≥150 mg/dL at baseline are eligible. During the study period, a total of 256 study participants will be randomised to receive either intensive TG-lowering therapy or usual care. In the intensive TG-lowering therapy group, the goal of TG levels is lower than 150 mg/dL, which will be monitored at 1 month, 3 months, 6 months, 12 months and 18 months after randomisation. In the usual care group, the goal of TG levels is lower than 500 mg/dL according to the current guidelines. Lifestyle suggestions and TG-lowering agents are the main strategies to manage the lipid level. The primary endpoint is the incidence of recurrent episodes of HTG-AP at 18 months after randomisation.

This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University (No. 2023101–3). Ethics approval of each participating centre is required before initiation of enrolment. The results of this study will be published in peer-reviewed journals and reported at international conferences.

ChiCTR2300073483 (Chinese Clinical Trial Registry)

V.4.0 (2024).

The incidence of alcoholic liver cirrhosis (ALC) has been gradually rising in recent years, with a poor prognosis. This study aimed to investigate the association between the red blood cell distribution width–platelet ratio (RPR) and the in-hospital mortality risk among patients with ALC.

A total of 1424 patients with ALC were extracted from the Medical Information Mart for Intensive Care IV for carrying out this retrospective study. Based on the value of RPR, the included patients were divided into quartiles. The association between RPR and in-hospital mortality risk in patients with ALC, both with and without severe liver disease, was initially examined using Kaplan-Meier (KM) curves. Subsequently, restricted cubic splines (RCS) and multivariable Cox proportional hazards models were used to assess the relationship between RPR and in-hospital mortality. Subgroup analyses also explored the effect modifications by clinical covariates.

Among the 1424 patients with ALC included, 778 were present with and 646 without severe liver disease. KM curves, RCS and multifactorial COX regression analyses suggested that patients in the first quartile (Q1) of RPR had the lowest in-hospital mortality risk, while those in the third quartile (Q3) had the highest. Among patients with total ALC, after the adjustment for all covariates, the HR for Q3 was 1.64 (95% CI 1.29 to 2.08, p0.05). Subgroup analysis revealed that factors such as age, blood pressure and medical history may affect the association between RPR and in-hospital mortality.

This study demonstrated a significant association between elevated RPR levels and increased in-hospital mortality risk in patients with ALC, including those with severe liver disease.

Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.

CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient’s home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.

214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.

The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.

CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.

ISRCTN11380842.

Pain is one of the most bothersome symptoms that affects patients with inflammatory bowel disease (IBD) but is often inadequately treated. Inadequate pain control in the inpatient setting not only impacts patients’ experience but increases opioid use and hospital length of stay. Opioids are often considered first-line treatment for severe pain but are associated with significant morbidity and mortality in IBD. Non-steroidal anti-inflammatory drugs are a non-opioid analgesic option, but concerns regarding their contribution to IBD flares have limited their use. Brain-gut behavioural therapies (BGBT), such as cognitive behavioural therapy, meditation and gut-directed hypnotherapy, are effective for pain management and have a role in the treatment of IBD symptoms. However, the use of BGBT in IBD is challenging, given limited access to behavioural health specialists, especially in the inpatient setting. Virtual reality (VR)-directed BGBT programmes can bridge this gap and enhance pain treatment for inpatients with IBD. Therefore, in this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.

We will recruit 40 patients with IBD who are hospitalised at Michigan Medicine and who endorse IBD-related pain. We will assess patient-reported outcomes (pain rating, IBD-specific symptoms, perceived stress, mood) before and after treatment, cumulative inpatient analgesic requirements and hospital length of stay. Our primary objective will be to establish intervention feasibility defined by the frequency and percentage of enrolled participants that use the VR-directed BGBT inpatient intervention in any capacity. Our secondary objective will be to evaluate intervention acceptability by conducting semistructured interviews with study participants. We will also explore the preliminary effectiveness of VR-directed BGBT on patient-reported outcomes and healthcare utilisation as compared with historic controls.

The study was approved by the institutional review board of the University of Michigan Medical School on 10 October 2023 (HUM00240999). All human subjects will be required to sign an informed consent document prior to study participation. Study findings will be reported through peer-reviewed publication.

NCT06188793.

Low-level viremia (LLV) is a risk factor affecting the prognosis of patients with chronic hepatitis B (CHB). The objective of this study was to systematically assess the prevalence of LLV, thereby providing robust evidence-based medical insights into effective clinical interventions and preventative measures against LLV.

Systematic review and meta-analysis.

A comprehensive literature search was conducted across various databases, including China National Knowledge Infrastructure, Wanfang Data (Wanfang), China Science And Technology Journal Database (VIP-CSTJ), China Biology Medicine disc (CBMdisc), PubMed, Embase, Web of Science and the Cochrane Library, spanning from the inception of these databases up to 5 January 2024.

The research type included either a cross-sectional study or a cohort study focusing on the Chinese population, with the outcome being LLV. The languages were limited to both Chinese and English. Studies with any of the following were excluded: subjects with other comorbidities, original articles inaccessible or data unavailable, and duplicate publications.

Literature management used EndNote X9.1, and an information extraction table was created using Microsoft Excel to record research information, including first author, year of publication and study type. The prevalence of LLV was assessed via meta-analysis. Meta-analyses were conducted in RStudio using the ‘metaprop ()’ function. Subgroup analysis and sensitivity analysis were used to identify sources of heterogeneity, and funnel plots and AS-Thompson tests were employed to evaluate publication bias.

18 studies, encompassing a total sample of 9773 patients, were included in the analysis. Of these, 3336 patients were identified with LLV. The meta-analysis revealed that the prevalence of LLV among treated CHB patients stands at 33.6% (95% CI 30.2 to 37.0). The antigen status, antiviral treatment regimen (type of drugs and nucleos(t)ide analogues (NAs)), treatment duration, medication adherence and baseline hepatitis B virus DNA levels all affected the prevalence of LLV. Sensitivity analysis further corroborated the stability of these meta-analysis findings. The funnel plot and AS-Thompson test indicated no significant publication bias (t = –0.01, p=0.995).

The prevalence of LLV among CHB patients was established at 33.7% (95% CI 29.8% to 37.6%). Thus, it is imperative for clinical decision-makers to consider the various influencing factors of LLV when formulating treatment plans in order to mitigate any potential adverse outcomes.

As a disorder of gut–brain interaction, irritable bowel syndrome (IBS) is a common reason for patient visits in primary and specialist care settings. IBS is associated with recurrent abdominal pain, altered bowel habit, resulting in alternating constipation and diarrhoea, bloating, without serious organic diseases. The bidirectional relationship between IBS and psychological factor is also complex. Studies have suggested that tricyclic antidepressants can effectively control the concomitant symptoms of IBS, especially some severe and refractory symptoms. At present, the conventional treatment of IBS remains somewhat unsatisfactory. Studies have shown that the antidepressant effects of esketamine are rapid and significant, whether a single low dose of esketamine is effective in IBS deserves further investigation. In this study, we hypothesise that a single low dose of esketamine will be effective for IBS.

This is a single-centre, randomised, double-blind, placebo-controlled trial. Patients with IBS are divided into three levels according to the severity of IBS: mild, moderate and severe. 92 patients in the esketamine group and 92 patients in the control group who are scheduled for colonoscopy will be prospectively recruited in each level. The primary outcome is the IBS Severity Scoring System at baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy. The secondary outcome includes IBS-Quality of Life, Bristol Stool Form scale, Hospital Anxiety and Depression Scale, Patient Health Questionnaire-12 Somatic Symptom Score and adverse events. The allocation sequence is assigned by a random number table using a block randomisation method by SPSS (Version 26, IBM Inc., USA) Statistics software. All enrolled patients, anaesthesiologist B and researchers responsible for follow-up and data collection and analysis are therefore fully blinded. All data will be performed using SPSS Statistics software, and a p value

The protocol has been approved by the Medical Ethics Committee of Beijing Tiantan Hospital affiliated to Capital Medical University (KY2024-414-02). All participants will sign a written informed consent form. The results will be submitted for publication in peer-reviewed journals, presented at international conferences, and shared with participants via hospital newsletters.

Efficacy of Esketamine for Patients With Irritable Bowel Syndrome (NCT06788444).

Concurrent with infants’ progression in dietary complexity and gut microbiome diversity, infants gradually change their defecation patterns during the first year of life. However, the links between bowel habits, the gut microbiota and early life nutrition remain unclear. The primary outcome is to characterise the gut microbiome development from birth to 1 year of age. Second, to investigate how bowel habits and nutrition in early life relate to the gut microbiome and metabolome during this period of life, and to explore how the development of the gut microbiome associates with host development.

The MOTILITY Mother-Child Cohort (MOTILITY) is a Danish prospective longitudinal cohort study enrolling up to 125 mother–infant dyads. Assessments occur at 36 weeks gestation (visit 1), birth (screening of infant) and 3, 6, 9 and 12 months (±2 weeks) post partum (visits 2–5). At visit 1, maternal anthropometrics, self-collected faecal and urine samples, and questionnaires on bowel habits and lifestyle are obtained. Between visits, infant faecal (biweekly), urine (monthly) and maternal breast milk (monthly until 6 months of age) samples are collected at home, and bowel habits and dietary intake are assessed biweekly by self-reported questionnaires. At visits 2–5, infant blood and saliva samples are collected, and anthropometric measurements are obtained. In addition, dietary intake is recorded thrice throughout the study period for mother and infant, respectively, and infant whole-gut transit time is estimated by sweet corn tests at 9 and 12 months of age. Birth, growth, motor development, sleep patterns, tooth development, overall health and well-being are assessed using questionnaires. Univariate and multivariate statistics will be applied to identify associations between the gut microbiome, early life nutrition and host physiology including bowel habits during the first year of life.

The MOTILITY study has been approved by the Research Ethics Committee for the Capital Region of Denmark (reference number: H-21063016). Selected results will be made available to the participants in the form of a summary document. Results will be published in peer-review journals and by means of national and international conferences.

NCT05491161.

To examine the knowledge, attitude and practice (KAP) regarding immune-related adverse events (irAEs) and nutritional support among patients with liver cancer (LC).

Cross-sectional study.

Recruitment was carried out at Haikou People’s Hospital, Haikou, China, from December 2022 to April 2023.

Patients undergoing immunotherapy for LC.

Mean knowledge, attitudes, practices, and lifestyle scores were assessed using an investigator-designed questionnaire completed by patients during immunotherapy.

The study included 402 participants. The mean knowledge, attitudes, practices and lifestyle scores were 6.60±3.51 (/10, 66.00%), 41.26±5.06 (/50, 82.52%), 30.74±4.20 (/40, 76.85%) and 42.37±6.04 (/55, 77.04%), respectively. Attitude scores were associated with practice scores (β=0.381, p

Patients with LC and undergoing immunotherapy had moderate KAP towards irAEs and nutritional support. They also displayed moderate lifestyle scores. Urban residents, people not living alone, females and those having received two or more immunotherapy treatments were positively associated with attitude, while attitude was positively associated with practice and lifestyle.

American College of Gastroenterology (ACG) and Chinese expert consensus recommended different algorithmic approaches for the diagnosis of gastro-oesophageal reflux disease (GERD) are not yet defined. We compared the two recommended diagnostic processes using a Chinese population-based health economics analysis.

Our analysis considered a hypothetical cohort of patients with typical reflux symptoms. We constructed a decision tree model to compare the two recommended diagnostic processes described in ACG clinical guidelines (stratified endoscopy strategy) and Chinese expert consensus (endoscopy-first strategy). The first strategy begins with hazard stratification based on alarm symptoms. Patients with alarm symptoms directly undergo endoscopic examination, while patients without alarm symptoms receive proton pump inhibitors as diagnostic treatment. In the second strategy, all patients with reflux symptoms complete an endoscopic examination. Sensitivity analysis was performed to evaluate a range of cost and probability estimates on costs and health outcomes over a 1-year time horizon from the healthcare system perspective.

The total expected costs were US$122.51 for the stratified endoscopy strategy and US$150.12 for the endoscopy-first strategy. The incremental cost-effectiveness ratio (ICER) comparing the endoscopy-first strategy with the stratified endoscopy strategy was US$440.39 per additional correct case of GERD. The rates of detecting upper gastrointestinal carcinoma of the two strategies were 0.0088 and 0.0120, and the ICER was US$8561.34.

The use of endoscopy for all patients with reflux symptoms was more effective but with an increased cost compared with the strategy recommended in international guidelines.