Protocol for a randomised, double-blind, placebo-controlled trial assessing Enterosgel® for functional abdominal pain in children (ENTOPIC)
This document is a study protocol — no efficacy or safety data have been collected or analysed; effect direction is insufficient.
| Population | Children and young people aged 3–18 years diagnosed with a FAPD (IBS, functional dyspepsia, abdominal migraine, or functional abdominal pain not otherwise specified) at two UK centres |
|---|---|
| Intervention | Enterosgel® (polyhydrated polymethylsiloxane, silicon-based medical device) administered twice daily for 4 weeks (double-blind phase) followed by 4 weeks open-label |
| Comparator | Matching placebo drink administered twice daily for 4 weeks |
| Outcome | Daily abdominal pain score (Wong-Baker FACES); Gastrointestinal symptoms (PedsQL 3.0 GIS); Health-related quality of life (KIDSCREEN-27); Safety and tolerability |
Summary of findings
| Outcome | Effect | 95% CI | Certainty | Clinical relevance | Notes |
|---|---|---|---|---|---|
| Daily abdominal pain score (Wong-Baker FACES) | not reported — protocol only | — | Very low | — | |
| Gastrointestinal symptoms (PedsQL 3.0 GIS) | not reported — protocol only | — | Very low | — | |
| Health-related quality of life (KIDSCREEN-27) | not reported — protocol only | — | Very low | — | |
| Safety and tolerability | not reported — protocol only | — | Very low | — |
Context
Functional abdominal pain disorders (FAPDs) affect children worldwide and impair quality of life and school attendance comparably to inflammatory bowel disease. No treatment has demonstrated significant efficacy in this population. Enterosgel® showed efficacy in adult IBS-D but no paediatric controlled trial data exist.
What the study showed
This is a published protocol — no results are available. The trial has not yet been conducted or, if initiated, data have not been analysed. No effect size, 95% CI, or p-value can be reported.
How it was done
Parallel-arm, 1:1 randomised, double-blind, placebo-controlled trial at two UK centres. Total duration 10 weeks per participant (2-week observation + 4-week double-blind + 4-week open-label). All post-initial-assessment procedures conducted remotely with interventions posted to participants.
Effect magnitude
Not applicable — protocol without data. Sample size and statistical power were not explicitly reported in the available text.
Risk of bias
The available text is a protocol only; absence of data precludes risk-of-bias assessment via RoB 2 or ROBINS-I. Design-level concerns include remote conduct (unverified adherence), a heterogeneous population (four FAPD subtypes pooled), and an uncontrolled open-label phase that may confound safety interpretation.
What this study does NOT prove
This document proves nothing about the efficacy or safety of Enterosgel® in children with FAPDs — it is a protocol. It has no clinical applicability until results are published.
In clinical practice
No change in clinical practice is supported by this protocol. Clinicians should await published ENTOPIC trial results before considering Enterosgel® for paediatric FAPDs outside a research context.
Limitations
The available text is a protocol only; absence of data precludes risk-of-bias assessment via RoB 2 or ROBINS-I. Design-level concerns include remote conduct (unverified adherence), a heterogeneous population (four FAPD subtypes pooled), and an uncontrolled open-label phase that may confound safety interpretation.
What is still missing
Primary trial data from ENTOPIC, including effect size, safety, and tolerability across age subgroups and FAPD subtypes.
Technical appendix
Version history
- 1.0 · 2026-10-25 — Auto-generated under Evidence Standard v1.0