Randomised, placebo-controlled study to assess the safety and efficacy of Enterosgel® in the treatment of functional abdominal pain in children and young people (ENTOPIC): study protocol for a clinical trial

Functional abdominal pain disorders (FAPDs) comprise of irritable bowel syndrome, functional dyspepsia, abdominal migraine and functional abdominal pain not otherwise specified. FAPDs are common in children worldwide, decrease health related quality of life, reduce attendance and participation in school and after-school activities similar to children with inflammatory bowel disease, and incur significant health care costs. The aetiology is thought to involve structural and/or functional disruptions in one or more elements of the microbiota–gut–brain axis. Several different treatment approaches are available, reflecting that none is proven to have significant efficacy. The medical device Enterosgel®, a silicon-based intestinal absorbent, adsorbs immune proteins, bacterial breakdown products and bile acids and normalises the intestinal microbiota. Enterosgel® is effective in irritable bowel syndrome with diarrhoea in adults and is available on prescription and over-the-counter. We plan to evaluate the efficacy, tolerability and safety of Enterosgel® in the treatment FAPDs in children and young people. In a UK two-centre, parallel arm, randomised, double-blind, placebo-controlled trial, we will recruit children aged 3–18 years diagnosed with a FAPD during a routine health facility assessment and in whom other significant gastrointestinal disorders have been excluded. After an initial 2-week observation phase, eligible children will be randomised 1:1 to receive Enterosgel® or a matching placebo drink twice daily for 4 weeks during the double-blind treatment phase, then all children will receive open-label Enterosgel® treatment for a further 4 weeks. With support from parents/carers, children will record abdominal pain daily using the Wong-Baker FACES Pain Rating Scale. The primary outcome is change in mean daily pain score during the initial observation phase and the double-blind phase in the Enterosgel® versus the placebo arm. Secondary outcomes include change in gastrointestinal symptoms (assessed PedsQL™ 3.0 GIS module) and quality of life (KIDSCREEN-27) recorded at baseline and 6 and 10 weeks. After the initial clinical assessment, all procedures will be conducted remotely with study interventions sent by post. In the absence of a currently available effective treatment, this study will assess the acceptability, efficacy and safety of Enterosgel® in the treatment of children and young people with FAPDs. ISRCTN ISRCTN16474818. Registered on 21 May 2025, https://www.isrctn.com/ISRCTN16474818