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NCT02469220 Clinical Trial

Diet Treatment of Patients With Ulcerative Colitis in Remission

Ulcerative Colitis Clinical Trial

Official title:
Diet Treatment of Patients With Ulcerative Colitis in Remission

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02469220
Other study ID # RHN_ALK_01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date April 26, 2022

Study information
Verified date April 2022
Source Vendsyssel Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date April 26, 2022
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Low FODMAP
Blinded food supplements containing only items with a low content of FODMAPs
• Standardized FODMAP
Blinded food supplements containing FODMAPs

Locations
Country Name City State
Denmark North Denmark Regional Hospital Hjørring Nordjylland

Sponsors (1)
Lead Sponsor Collaborator
Vendsyssel Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastrointestinal symptoms IBS-SSS questionnaire Week 8
Secondary Change in Quality of life SF-36 questionnaire Week 8
Secondary Pain diary VAS scales on a daily basis Daily during the study
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