Diet Treatment of Patients With Ulcerative Colitis in Remission

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02469220

Enrollment

Registered

2015-06-11

Start date

2018-07-01

Completion date

2022-04-26

Last updated

2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Diet, low FODMAP, UC, IBS

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.

Interventions

DIETARY_SUPPLEMENTLow FODMAP

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

DIETARY_SUPPLEMENTStandardized FODMAP

Blinded food supplements containing FODMAPs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Gastrointestinal symptoms	Week 8	IBS-SSS questionnaire

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026