Paediatric constipation Digestive System Constipation
Conditions
Interventions
This is a fully powered, multi-centre, open-label, pragmatic Randomised Controlled Trial (RCT) to test if the use of the TransiCap MRI visible capsules to inform treatment selection leads to a change
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 7 – 18 years old 2. Able to give assent/consent or have a parent/carer able to give informed consent 3. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical investigation 4. Children diagnosed with clinical diagnosis of constipation
Exclusion criteria
Exclusion criteria: 1. Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation. This will be self-reported 2. Any history of gastrointestinal surgery that could affect gastrointestinal function, such as colectomy or small bowel resection 3. Existing ACE procedure before the first MRI scan 4. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury 5. Inability to lie flat and relatively still for less than 5 minutes 6. Poor understanding of English language 7. The following disease or disorder: bowel stricture disease, Crohn’s or any difficulty in swallowing (dysphagia), Hirschsprung disease, congenital anorectal malformations, paediatric pseudo-obstruction syndrome 8. Currently using the following drugs influencing drug motility: 8.1. Opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co-codamol and codydramoland) 8.2. Antispasmodic Buscopan (hyoscine butylbromide, also known as scopolamine butylbromide) 9. Participants who have participated in another research clinical investigation involving an investigational product in the past 12 weeks. 10. 4 or more bowel movements in one week and no episodes of bowel incontinence in one week (if these are reported in the participant’s medical notes. Absence of this information should not warrant exclusion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success, defined as 3 or more bowel movements in one week and/or 1 or fewer episodes of bowel incontinence in one week, between the MRI-informed treatment versus standard treatment at 12 months after the final MRI visit (+/- 2 weeks). This will be measured using a patient stool diary at 12 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of Serious Adverse Events, measured via medical notes review at MRI visits, at 6 and 12 months follow up 2. Identification of any undesirable side effects (ADE’S) measured via medical notes review at MRI visits, at 6 and 12 months follow up 3. Number of TransiCap MRI visible capsules swallowed, collected by TransiCap questionnaire Day 1-3 4. Attendance at MRI scans measured using CRF at both MRI visits 5. Capsules visible on both scans (Intervention arm only) collected by MRI images/reports 6. Gut transit time (intervention arm only) calculated using MRI report at day 4 and day 7 7. Patient acceptability of swallowing the TransiCap MRI visible capsules (usability and acceptability performance) collected by TransiCap questionnaire on Day 1-3 8. Patient quality of life collected using EQ-5D-Y at baseline, day 0 and day 8, at 6 and 12 months follow up 9. Pain measured using EQ VAS score at baseline, day 0 – day 8, at 6 and 12 months follow up 10. Parents/carers quality of life measured using AC-QoL score at baseline, day 0 and day 8, at 6 and 12 months follow up 11. Patient symptoms (flatulence, bloating and abdominal pain) collected through patient stool diary at day 0 – day 6, at 6 and 12 months follow up 12. Stool shape collected through patient stool diary at day 0 – day 6, at 6 and 12 months follow up: 13. Number of people completing the MRI study measured using CRF at Day 8 14. Treatment selection measured by medical notes review at 6 and 12 months follow up 15. Treatment success collected through patient stool diary at 6 months follow up 16. Gut transit time used to inform treatment selection (intervention arm only) measured using CRF at 6 and 12 months follow up: 17. Capsules visible on both scans (control arm) collected by MRI images/reports at 12 months 18. Gut transit time (hours) (control arm) measured using MRI report at 12 months | — |
Countries
England, United Kingdom
Outcome results
None listed