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Diet Treatment of Patients With Ulcerative Colitis in Remission

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low FODMAP
Standardized FODMAP
Sponsored by
Vendsyssel Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ulcerative Colitis focused on measuring Diet, low FODMAP, UC, IBS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • North Denmark Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Low FODMAP diet

Standardized FODMAP

Control

Arm Description

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.

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.

Watchful waiting. No diets or food supplements are administered

Outcomes

Primary Outcome Measures

Gastrointestinal symptoms
IBS-SSS questionnaire

Secondary Outcome Measures

Change in Quality of life
SF-36 questionnaire
Pain diary
VAS scales on a daily basis

Full Information

First Posted
June 8, 2015
Last Updated
April 26, 2022
Sponsor
Vendsyssel Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02469220
Brief Title
Diet Treatment of Patients With Ulcerative Colitis in Remission
Official Title
Diet Treatment of Patients With Ulcerative Colitis in Remission
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vendsyssel Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Diet, low FODMAP, UC, IBS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low FODMAP diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Standardized FODMAP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Watchful waiting. No diets or food supplements are administered
Intervention Type
Dietary Supplement
Intervention Name(s)
Low FODMAP
Intervention Description
Blinded food supplements containing only items with a low content of FODMAPs
Intervention Type
Dietary Supplement
Intervention Name(s)
Standardized FODMAP
Intervention Description
Blinded food supplements containing FODMAPs
Primary Outcome Measure Information:
Title
Gastrointestinal symptoms
Description
IBS-SSS questionnaire
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in Quality of life
Description
SF-36 questionnaire
Time Frame
Week 8
Title
Pain diary
Description
VAS scales on a daily basis
Time Frame
Daily during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne L Krarup, PhD
Organizational Affiliation
North Denmark Regional Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeanette Soerensen, PhD-student
Organizational Affiliation
North Denmark Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Denmark Regional Hospital
City
Hjørring
State/Province
Nordjylland
ZIP/Postal Code
9800
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Diet Treatment of Patients With Ulcerative Colitis in Remission

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