| Title: |
Management of diarrhoea in patients with stable ulcerative colitis with low FODMAP diet, amitriptyline, ondansetron or loperamide: the MODULATE RCT |
| Authors: |
L. A. F. Moreau, A. C.; Brookes, M. J.; Graca, S.; Guthrie, E.; Hartley, S.; Houghton, L.; Kemp, K.; Kennedy, N. A.; McKenzie, Y.; Muir, D.; Loo Ow, P.; Probert, C.; Pryde, E.; Taylor, C.; Willis, T. A.; Wright-Hughes, A.; Farrin, A. J. |
| Contributors: |
Gastroenterology (Department of); Kennedy, Nicholas A |
| Publisher Information: |
NIHR Journals Library |
| Publication Year: |
2026 |
| Collection: |
RD&E Research Repository (Royal Devon and Exeter NHS Foundation Trust) |
| Subject Terms: |
Decentralised trial; Multiarm multistage; Platform trial; Randomised controlled trial; Ulcerative colitis |
| Description: |
BACKGROUND: Many patients with ulcerative colitis report ongoing diarrhoea even when their disease is stable and in remission. DESIGN: MODULATE was a pragmatic, multicentre, seamless, adaptive, phase 2/3 open-label, parallel-group, multiarm multistage randomised controlled trial. SETTING AND PARTICIPANTS: People aged over 18 years with stable ulcerative colitis who had diarrhoea, recruited from secondary care sites in the United Kingdom. INTERVENTIONS: The control arm consisted of modified first-line dietary advice given to all patients with irritable bowel syndrome; the first interventional arm was amitriptyline, a tricyclic antidepressant, which at low doses slows colonic transit; the second intervention was loperamide, an antidiarrhoeal drug also thought to slow colonic transit; the third was ondansetron, an antiemetic thought to slow colonic transit; and the fourth was a diet low in fermentable oligo-, di-, and mono-saccharides and polyols, which is thought to reduce bloating and gas within the small intestine. All patients randomised to an interventional arm were to receive treatment for 6 months. MAIN OUTCOME MEASURES: PRIMARY OUTCOME MEASURES: Phase 2: Improvement in diarrhoea measured using the Gastrointestinal Symptom Rating Scale-irritable bowel syndrome questionnaire at 8 weeks post randomisation: improvement defined as those reporting minor discomfort from diarrhoea or less (scoring = 2 on the diarrhoea subscale). SECONDARY OUTCOME MEASURES: Phases 2 and 3: Measured at both 8 weeks and 6 months: Improvement in diarrhoea measured using the Gastrointestinal Symptom Rating Scale-irritable bowel syndrome. Blood for C-reactive protein, stool for faecal calprotectin at 6 months only, reviewing case notes for escalation of medical therapy for ulcerative colitis. Anxiety and depression, via the Hospital Anxiety and Depression Scale. RESULTS: The MODULATE trial opened in December 2021 and closed in January 2023. Of the eight secondary care sites that completed contracting, only four opened to recruitment ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://pmc.ncbi.nlm.nih.gov/articles/pmid/40079650/; Health technology assessment; PMC11931405; https://hdl.handle.net/11287/623961 |
| DOI: |
10.3310/ghfe4871 |
| Availability: |
https://hdl.handle.net/11287/623961; https://doi.org/10.3310/ghfe4871 |
| Rights: |
© 2025 Moreau et al |
| Accession Number: |
edsbas.ED68EE93 |
| Database: |
BASE |