Diet Treatment of Patients With Ulcerative Colitis in Remission

April 26, 2022 updated by: Anne Lund Krarup, Vendsyssel Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Nordjylland
      • Hjørring, Nordjylland, Denmark, 9800
        • North Denmark Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vendsyssel Hospital

Investigators

  • Principal Investigator: Anne L Krarup, PhD, North Denmark Regional Hospital
  • Principal Investigator: Jeanette Soerensen, PhD-student, North Denmark Regional Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

April 26, 2022

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHN_ALK_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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