Diet Treatment of Patients With Ulcerative Colitis in Remission

NCT ID: NCT02469220

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2022-04-26

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low FODMAP

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: ACTIVE_COMPARATOR

Standardized FODMAP

Intervention Type: DIETARY_SUPPLEMENT

Blinded food supplements containing FODMAPs

Control

Watchful waiting. No diets or food supplements are administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low FODMAP

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

Intervention Type: DIETARY_SUPPLEMENT

Standardized FODMAP

Blinded food supplements containing FODMAPs

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regionshospital Nordjylland

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anne Lund Krarup

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne L Krarup, PhD

Role: PRINCIPAL_INVESTIGATOR

Regionshospital Nordjylland

Jeanette Soerensen, PhD-student

Role: PRINCIPAL_INVESTIGATOR

Regionshospital Nordjylland

Locations

North Denmark Regional Hospital

Hjørring, North Denmark, Denmark

Countries

Denmark

Other Identifiers

RHN_ALK_01

Identifier Type: -

Identifier Source: org_study_id