Impact of Prebiotics in Ulcerative Colitis

University of California, Los Angeles70 enrolled

Overview

The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD. Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Crohn Disease Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ages 18 to 85 years old * History of biopsy-proven ulcerative colitis (UC) * Active symptoms (SCCAI \>2) * Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment. * Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment. * Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial Exclusion Criteria: * Prior colectomy * Hospitalization * Urgent need for abdominal surgery * Unstable major medical condition * Active malignancy under treatment * Active alcohol or non-cannabinoid substance abuse * Pregnancy or lactation * Concerns for non-compliance

Outcomes

Primary Outcomes

Clinical remission

Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) \< 4. Range of SCCAI is 0-20 (higher is more severe).

Time frame: Week 8

Change in fecal calprotectin

Fecal calprotectin is a stool test that measures intestinal inflammation

Time frame: Week 8

Microbial composition

Microbial composition includes a measurement and characterization of the relative quantity of genera and species.

Time frame: Week 8

Secondary Outcomes

Clinical response

Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).

Time frame: Week 8

Clinical remission

Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) \< 4. Range of SCCAI is 0-20 (higher is more severe).

Time frame: Week 16

Clinical response

Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).

Time frame: Week 16

Change in fecal calprotectin

Fecal calprotectin is a stool test that measures intestinal inflammation

Time frame: Week 16

Microbial composition

Microbial composition includes a measurement and characterization of the relative quantity of genera and species.

Time frame: Week 16

Impact of Prebiotics in Ulcerative Colitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes