Impact of Prebiotics in Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis; Crohn Disease
• Interventions: Dietary Supplement: Prebiotic

• Registration Number: NCT06495658
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-03
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-07
• Study Start: 2024-07-09
• Study First Posted: 2024-07-11
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prebiotic at Week 8	Prebiotic	-
Prebiotic at Week 0	Prebiotic	-

Primary Outcome Measures

Name	Time	Method
Microbial composition	Week 8	Microbial composition includes a measurement and characterization of the relative quantity of genera and species.
Clinical response	Week 8	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).

Secondary Outcome Measures

Name	Time	Method
Microbial composition	Week 16	Microbial composition includes a measurement and characterization of the relative quantity of genera and species.
Clinical response	Week 16	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).
Clinical remission	Week 16	Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) \< 4. Range of SCCAI is 0-20 (higher is more severe).

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States