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AnteayerBMJ Open

Protocol for the Gut Bugs in Autism Trial: a double-blind randomised placebo-controlled trial of faecal microbiome transfer for the treatment of gastrointestinal symptoms in autistic adolescents and adults

Por: Tweedie-Cullen · R. Y. · Leong · K. · Wilson · B. C. · Derraik · J. G. B. · Albert · B. B. · Monk · R. · Vatanen · T. · Creagh · C. · Depczynski · M. · Edwards · T. · Beck · K. · Thabrew · H. · O'Sullivan · J. M. · Cutfield · W. S.
Introduction

Autism (formally autism spectrum disorder) encompasses a group of complex neurodevelopmental conditions, characterised by differences in communication and social interactions. Co-occurring chronic gastrointestinal symptoms are common among autistic individuals and can adversely affect their quality of life. This study aims to evaluate the efficacy of oral encapsulated faecal microbiome transfer (FMT) in improving gastrointestinal symptoms and well-being among autistic adolescents and adults.

Methods and analysis

This double-blind, randomised, placebo-controlled trial will recruit 100 autistic adolescents and adults aged 16–45 years, who have mild to severe gastrointestinal symptoms (Gastrointestinal Symptoms Rating Scale (GSRS) score ≥2.0). We will also recruit eight healthy donors aged 18–32 years, who will undergo extensive clinical screening. Recipients will be randomised 1:1 to receive FMT or placebo, stratified by biological sex. Capsules will be administered over two consecutive days following an overnight bowel cleanse with follow-up assessments at 6, 12 and 26 weeks post-treatment. The primary outcome is GSRS score at 6 weeks. Other assessments include anthropometry, body composition, hair cortisol concentration, gut microbiome profile, urine/plasma gut-derived metabolites, plasma markers of gut inflammation/permeability and questionnaires on general well-being, sleep quality, physical activity, food diversity and treatment tolerability. Adverse events will be recorded and reviewed by an independent data monitoring committee.

Ethics and dissemination

Ethics approval for the study was granted by the Central Health and Disability Ethics Committee on 24 August 2021 (reference number: 21/CEN/211). Results will be published in peer-reviewed journals and presented to both scientific and consumer group audiences.

Trial registration number

ACTRN12622000015741.

Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol

Por: PelvEx Collaborative · West · West · Drami · Denys · Glyn · Sutton · Tiernan · Behrenbruch · Guerra · Waters · Woodward · Applin · Charles · Rose · Pape · van Ramshorst · Mirnezami · Aalbers · Abdul Aziz · Abecasis · Abraham-Nordling · Akiyoshi · Alahmadi · Alberda · Albert · And
Introduction

The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. ‘PelvEx—Beating the empty pelvis syndrome’ aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome.

Methods and analysis

A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting.

Ethics and dissemination

The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome.

Trial registration number

NCT05683795.

Treatment of schizotypal disorder: a protocol for a systematic review of the evidence and recommendations for clinical practice

Por: Gundersen · K. B. · Rasmussen · A. R. · Sandström · K. O. · Albert · N. · Polari · A. · Ebdrup · B. H. · Nelson · B. · Glenthoj · L. B.
Introduction

Schizotypal disorder is associated with a high level of disability at an individual level and high societal costs. However, clinical recommendations for the treatment of schizotypal disorder are scarce and based on limited evidence. This review aims to synthesise the current evidence on treatment for schizotypal disorder making recommendations for clinical practice.

Methods and analysis

This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic literature search will be performed in PsychArticles, Embase, Medline and Cochrane Central Register of Controlled Trials. Additionally, we will search for relevant articles manually. Inclusion criteria are published studies including individuals diagnosed with schizotypal personality disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria, or schizotypal disorder according to International Classification of Diseases (ICD) criteria. We will include interventional studies comprising any pharmacological and non-pharmacological treatment trials for patients with schizotypal disorder, and all relevant outcome measures will be reported. Risk of bias will be assessed by Cochrane risk-of-bias tools. Data will be synthesised using narrative or thematic analysis and, if suitable, through meta-analysis.

Ethics and dissemination

No original data will be collected as part of this study and ethics approval is, therefore, not applicable. The results will be disseminated through peer-reviewed publication and presented at international scientific meetings. We will aim at submitting the final paper for publication within 4 months of completion of analyses. Furthermore, this systematic review will inform clinicians and researchers on the current state of evidence on treatment for schizotypal disorder. Findings may guide proposals for further research and potentially guide recommendations for clinical practice using the Grading of Recommendations Assessment, Development and Evaluation.

PROSPERO registration number

CRD42022375001.

'They say: medical students perceptions of General Practice, experiences informing these perceptions, and their impact on career intention--a qualitative study among medical students in England

Por: Banner · K. · Alberti · H. · Khan · S. A. · Jones · M. M. · Pope · L. M.
Objectives

The number of UK graduates choosing General Practice training remains significantly lower than the current numbers required to meet the demands of the service. This work aims to explore medical students’ perceptions of General Practice, experiences which lead to the development of these perceptions, and the ultimate impact of these on career intention.

Design

This mixed-methods, qualitative study used focus groups, semistructured interviews, longitudinal audio diary data and debrief interviews to explore and capture the experiences and perceptions of students in their first and penultimate years of university.

Setting

Three English medical schools.

Participants

Twenty students were recruited to focus groups from first and fourth/fifth year of study. All students in these years of study were invited to attend. Six students were recruited into the longitudinal diary study to further explore their experiences.

Results

This work identified that external factors, internal driving force and the ‘they say’ phenomenon were all influential on the development of perceptions and ultimately career intention. External factors may be split into human or non-human influences, for example, aspirational/inspirational seniors, family, peers (human), placements and ‘the push’ of GP promotion (non-human). Driving force refers to internal factors, to which the student compares their experiences in an ongoing process of reflection, to understand if they feel General Practice is a career they wish to pursue. The ‘they say’ phenomenon refers to a passive and pervasive perception, without a known source, whereby usually negative perceptions circulate around the undergraduate community.

Conclusion

Future strategies to recruit graduates to General Practice need to consider factors at an undergraduate level. Positive placement experiences should be maximised, while avoiding overtly ‘pushing’ GP onto students.

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