Diet Treatment of Patients With Ulcerative Colitis in Remission

Not Applicable

Completed

• Conditions: Ulcerative Colitis
• Interventions: Dietary Supplement: Standardized FODMAP; Dietary Supplement: Low FODMAP

• Registration Number: NCT02469220
• Lead Sponsor: Vendsyssel Hospital

Brief Summary

The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.

Detailed Description

Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet. Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded food supplement with low FODMAP content and the other arm is assigned a blinded food supplement containing FODMAP. A control group is "watchful waiting".

Symptom reports, blood, and fecal samples are collected.

Study Timeline

• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Study Start: 2018-07-01
• Primary Completion: 2020-08-31
• Status Verified: 2022-04
• Study Completion: 2022-04-26
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Colitis ulcerosa in remission (calciprotectin<200 and normal sigmoidoscopy)
• ROM IV criteria fullfilled
• Stable medical therapy

Exclusion Criteria

• Intake of a low FODMAP diet within the past 6 weeks prior to baseline
• Atypical colitis ulcerosa primarily right sided disease and calciprotectin >50 unless normal sigmoidoscopy
• If diarrhea: Clostridium difficile infection
• Lactose intolerance
• Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological therapy
• Antibiotics within 6 weeks
• Pregnancy
• Activity in UC
• Coeliac disease
• Abnormal transglutaminase
• Eating disorder
• Special diet preventing the low FODMAP diet
• Other GI disease or other disease explaining symptoms
• Medication intake explaining symptoms
• Not able to follow protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardized FODMAP	Standardized FODMAP	Diet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement with FODMAPS are administered in a blinded fashion.
Low FODMAP diet	Low FODMAP	Diet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement low in FODMAPS are administered in a blinded fashion.

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms	Week 8	IBS-SSS questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life	Week 8	SF-36 questionnaire
Pain diary	Daily during the study	VAS scales on a daily basis

Trial Locations

Locations (1)

North Denmark Regional Hospital; 🇩🇰 Hjørring, Nordjylland, Denmark