Diet Treatment of Patients With Ulcerative Colitis in Remission
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- Vendsyssel Hospital
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Gastrointestinal symptoms
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Anne Lund Krarup
MD, PhD
Vendsyssel Hospital
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
Outcomes
Primary Outcomes
Gastrointestinal symptoms
Time Frame: Week 8
IBS-SSS questionnaire
Secondary Outcomes
- Change in Quality of life(Week 8)
- Pain diary(Daily during the study)