Diet Treatment of Patients With Ulcerative Colitis in Remission

Regionshospital Nordjylland19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

Low FODMAPDIETARY_SUPPLEMENT

Blinded food supplements containing only items with a low content of FODMAPs

Standardized FODMAPDIETARY_SUPPLEMENT

Blinded food supplements containing FODMAPs

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

North Denmark Regional Hospital

Hjørring, North Denmark, Denmark

Outcomes

Primary Outcomes

Gastrointestinal symptoms

IBS-SSS questionnaire

Time frame: Week 8

Secondary Outcomes

Change in Quality of life

SF-36 questionnaire

Time frame: Week 8

Pain diary

VAS scales on a daily basis

Time frame: Daily during the study

Data from ClinicalTrials.gov

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