Diet Treatment of Patients With Ulcerative Colitis in Remission

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diet Treatment of Patients With Ulcerative Colitis in Remission

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Dietary Supplement: Low FODMAP
* Dietary Supplement: Standardized FODMAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low FODMAP diet<br>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. | Dietary Supplement: Low FODMAP<br>* Blinded food supplements containing only items with a low content of FODMAPs<br>|
| Active Comparator: Standardized FODMAP<br>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. | Dietary Supplement: Standardized FODMAP<br>* Blinded food supplements containing FODMAPs<br>|
| No Intervention: Control<br>Watchful waiting. No diets or food supplements are administered | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms | IBS-SSS questionnaire | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life | SF-36 questionnaire | Week 8 | 
| Pain diary | VAS scales on a daily basis | Daily during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, low FODMAP, UC, IBS