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Exploring potential pathogenesis mechanisms of onchocerciasis-associated epilepsy through cerebrospinal fluid analysis of children with complex febrile seizures: a pilot study in Aketi, Democratic Republic of the Congo

Por: Kungu Gbulu · R. · De Wilde · B. · Lubbers · C. · Falay · D. S. · Siewe Fodjo · J. N. · Colebunders · R.
Introduction

Onchocerciasis, commonly known as river blindness, is a parasitic disease caused by Onchocerca volvulus affecting millions predominantly in sub-Saharan Africa. Robust epidemiological evidence points to a clinical relationship between onchocerciasis and epilepsy, a condition termed onchocerciasis-associated epilepsy (OAE). Despite extensive research and various successful elimination programmes over the past decades, the pathogenesis of OAE is still unknown. Current hypotheses propose that O. volvulus microfilaria, their excretory-secretory products or the newly discovered filarial O. volvulus RNA virus 1 (OVRV1) virus may traverse the blood-brain barrier, triggering seizures or immune responses that result in neurological damage. However, direct evidence of microfilaria or their DNA in cerebrospinal fluid (CSF) or brain tissue remains elusive, likely due to immune-mediated parasite clearance. Additionally, investigations into the potential neurotoxicity of these novel filarial viruses have yet to be pioneered.

Methods and analysis

This prospective cohort study will involve 100 ivermectin-naïve children aged 2–5 years, recruited from rural communities in the Aketi health zone, located in the Democratic Republic of Congo. This region is known to be an onchocerciasis-endemic area with a high prevalence and transmission of OAE, despite years of community-directed treatment with ivermectin. Lumbar punctures (LP) will be performed in children presenting with complex febrile seizures according to WHO’s paediatric guidelines. CSF samples will be examined for white blood cells, protein levels, glycorrhachia, microfilaria, OVRV1 and O. volvulus biomarkers. Children will be followed annually, monitoring the development of epilepsy and O. volvulus infection. This approach aims to elucidate the presence of O. volvulus and OVRV1 in the brain and their role in the pathogenesis of epileptic seizures and the myriad of clinical symptoms observed in OAE.

Ethics and dissemination

The protocol has been approved by the Ethics Committee of the University of Kisangani (UNIKIS/CE/KGB/001/2025) and the University of Antwerp (project ID 7323-Edge n/a-BUN B3002025000078). Written informed consent will be obtained from all parents and/or legal guardians of children for whom an LP is considered. Findings will be disseminated at national and international levels via meetings and peer-reviewed open-source publications. Study data will be stored in an open repository.

Trial registration number

Pan African Clinical Trials Registry (PACTR202507670131109).

Polyp prophylactic properties of polyacetylenes from carrots in patients with previous polypectomy--Px7 The study protocol of a multicentre binational randomised controlled trial

Por: Agache · A. · Deding · U. · Kaalby · L. · Kobaek-Larsen · M. · Al-Najami · I. · Ostergaard Hansen · L. · Stryhn · C. · Wilde · D. · Forsberg · A. · Backman · A.-S. · Bates · T. · de Lange · T. · Martling · A. · Baatrup · G.
Introduction

A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.

Methods and analysis

We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.

Ethics and dissemination

Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.

Trial registration number

NCT06335420.

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