Randomised, placebo-controlled study to assess the safety and efficacy of ENterosgel® in the Treatment Of functional abdominal Pain In Children and young people
Treatment of abdominal pain in children and young people with functional abdominal pain disorders
The intervention is Enterosgel® an intestinal adsorbent classified as a medical device class IIA since 2011 in Europe. Currently indicated for symptomatic treatment of acute diarrhoea and irritable bowel syndrome with diarrhoea (IBS-D), available and an OTC and on prescription in the UK. Enterosgel® is a tasteless gel that is mixed in water and taken orally. The dose is age dependent as per the Instructions for use. During the double-blind phase (4 weeks) patients will be randomised 1:1 to receive Enterosgel® or placebo, pre-mixed in water and dispensed in tubes ready to drink. During the open label phase Enterosgel® will be dispensed in tubes as a gel, ready to measure and then mix in water. This is followed by the 4 week open label phase for all participants allocated Enterosgel intervention. At the end of this phase participants return to standard care. Randomisation will be using a computer-based randomisation tool (Red Pill) within the eCRF (Sealed Envelope Ltd, UK), accessible once the eligibility criteria are confirmed.
Current inclusion criteria as of 14/08/2026: 1. Written informed consent 2. Children aged 3-18 years (parent/carer available to provide proxy-report and/or parent/carer report) with a clinical diagnosis of FAPD (Group H2) according to the Rome IV criteria 3. Considered suitable to take part in the study by the consenting investigator 4. Diary completed on at least 11 days (≥75%) during the observational period 5. Able to complete questionnaires in English 6. Able to complete e-diary and questionnaires online Previous inclusion criteria: 1. Written informed consent 2. Children aged 3-18 years (parent/carer available to provide proxy-report and/or parent/carer report) with a clinical diagnosis of FAPD (Group H2) according to the Rome IV criteria 3. Normal faecal calprotectin at FAPD diagnosis (≤250 ug/g stool age 3-8 yrs, ≤100 ug/g stool age 9-18 yrs) 4. Considered suitable to take part in the study by the consenting investigator 5. Diary completed on at least 11 days (≥75%) during the observational period 6. Able to complete questionnaires in English 7. Able to complete e-diary and questionnaires online
1. Previously diagnosed coeliac disease, inflammatory bowel disease or other significant gastrointestinal disorder 2. Average number of stools per week <3 3. Previous use of Enterosgel® 4. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks 5. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids 6. Participation in any research where treatment is provided in the last three months 7. Pregnancy or not willing to use contraception for the duration of the study in females of childbearing potential defined as any female over 11 years of age and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal