Treatment of abdominal pain in children and young people with Functional abdominal pain disorders. Digestive System
Conditions
Interventions
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 b
Sponsors
Enteromed Ltd
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
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 on-line
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed coeliac disease, inflammatory bowel disease or other significant gastro-intestinal 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the change in mean daily Wong-Baker FACES Pain Rating Scale (limited to abdominal pain) during weeks 1-2 (initial observation phase) and the double-blind phase (week 3-6) recorded in the daily diary in the Enterosgel® versus the placebo arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the Enterosgel® versus the placebo arm during the double-blind treatment phase and open-label treatment phase: 1. mean daily Wong-Baker FACES Pain Rating Scale recorded in the daily diary 2. The proportion of days with any abdominal pain 3. The proportion of days missed nursery/school 4. Change in the Stomach Pain and Hurt total score (comprised of 6 items) of the PedsQL 3.0 GIS module (parent/carer proxy-report for 3-4-year-olds and child self-report from 5-18 years; by parent/carer proxy-report for 3-18-year-olds) 5. Change in other individual components of the PedsQL 3.0 GIS module (parent/carer proxy-report for 3-4-year-olds and child self-report from 5-18 years; by parent/carer proxy-report for 3-18 years olds): stomach discomfort when eating (5 items), food and drink limits (6), trouble swallowing (3), heartburn and reflux (4), nausea and vomiting (4), gas and bloating (7), constipation (14), blood in bowel movement (2), diarrhoea (7), worry about bowel movements (5), medicines (4), communication (5). 6. Change in total PedsQL 3.0 GIS module score (parent/carer proxy-report for 3-4-year-olds and child self-report from 5-18 years; by parent/carer proxy-report for 3-18 years olds) 7. Change in health-related quality of life KIDSCREEN-27 questionnaire for children 8-18 years (child report and parent/carer proxy-report) 8. Acceptability of the study interventions (daily diary) 9. Adverse Events | — |
Countries
England, United Kingdom
Contacts
Public ContactCarol Howell
Outcome results
None listed