Impact of Prebiotics in Ulcerative Colitis

The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis

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 Overview

• Status: Recruiting
• Conditions: Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Dietary supplement: Prebiotic

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA
      • Contact: Berkeley Limketkai, MD, PhD; Phone Number: 8554238252; Email: berkeley.limketkai@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prebiotic at Week 0	Dietary supplement: Prebiotic; Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.
Active Comparator: Prebiotic at Week 8	Dietary supplement: Prebiotic; Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial composition	Microbial composition includes a measurement and characterization of the relative quantity of genera and species.	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).	Week 8
Change in fecal calprotectin	Fecal calprotectin is a stool test that measures intestinal inflammation	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 8
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).	Week 16
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).	Week 16
Microbial composition	Microbial composition includes a measurement and characterization of the relative quantity of genera and species.	Week 16
Change in fecal calprotectin	Fecal calprotectin is a stool test that measures intestinal inflammation	Week 16

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: July 7, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Dietary Fiber; Polysaccharides, Bacterial; Prebiotics
• Other Study ID Numbers: 24-000256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No