Diet Treatment of Patients With Ulcerative Colitis in Remission
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2022
CompletedApril 27, 2022
April 1, 2022
2.2 years
June 8, 2015
April 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastrointestinal symptoms
IBS-SSS questionnaire
Week 8
Secondary Outcomes (2)
Change in Quality of life
Week 8
Pain diary
Daily during the study
Study Arms (3)
Low FODMAP diet
EXPERIMENTALDiet 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.
Standardized FODMAP
ACTIVE COMPARATORDiet 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.
Control
NO INTERVENTIONWatchful waiting. No diets or food supplements are administered
Interventions
Blinded food supplements containing only items with a low content of FODMAPs
Eligibility Criteria
You may qualify if:
- Colitis ulcerosa in remission (calciprotectin\<200 and normal sigmoidoscopy)
- ROM IV criteria fullfilled
- Stable medical therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Denmark Regional Hospital
Hjørring, North Denmark, 9800, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne L Krarup, PhD
Regionshospital Nordjylland
- PRINCIPAL INVESTIGATOR
Jeanette Soerensen, PhD-student
Regionshospital Nordjylland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 8, 2015
First Posted
June 11, 2015
Study Start
July 1, 2018
Primary Completion
August 31, 2020
Study Completion
April 26, 2022
Last Updated
April 27, 2022
Record last verified: 2022-04