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OpenTrials
Completed

NCT Number: NCT02469220

Diet Treatment of Patients With Ulcerative Colitis in Remission

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Denmark Regional Hospital

Hjørring, North Denmark, 9800, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low FODMAP

Dietary Supplement

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

Standardized FODMAP

Dietary Supplement

Blinded food supplements containing FODMAPs

Primary outcomes

  1. Gastrointestinal symptoms

    Time frame: Week 8

    IBS-SSS questionnaire

Secondary outcomes

  1. Change in Quality of life

    Time frame: Week 8

    SF-36 questionnaire

  2. Pain diary

    Time frame: Daily during the study

    VAS scales on a daily basis

Sponsors and collaborators

Lead sponsor

Regionshospital Nordjylland

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jun 11, 2015
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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