Diet Treatment of Patients With Ulcerative Colitis in Remission

Vendsyssel Hospital

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Dietary Supplement: Low FODMAP; Dietary Supplement: Standardized FODMAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02469220

RHN_ALK_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 3 patient groups

Low FODMAP diet

Experimental group

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.

Treatment:

Dietary Supplement: Low FODMAP

Standardized FODMAP

Active Comparator group

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.

Treatment:

Dietary Supplement: Standardized FODMAP

Control

No Intervention group

Description:

Watchful waiting. No diets or food supplements are administered