Impact of Prebiotics in Ulcerative Colitis

NCT06495658 | Recruiting

• 1 other identifier: 24-000256
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• 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

• Microbial composition

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

  Week 8

Secondary Outcomes (5)

• Clinical response

  Week 8

• Clinical remission

  Week 16

• Clinical response

  Week 16

• Change in fecal calprotectin

  Week 16

• Microbial composition

  Week 16

Study Arms (2)

Prebiotic at Week 0

EXPERIMENTAL

Dietary Supplement: Prebiotic

Prebiotic at Week 8

ACTIVE COMPARATOR

Dietary Supplement: Prebiotic

Interventions

Prebiotic DIETARY_SUPPLEMENT

Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.

Prebiotic at Week 0; Prebiotic at Week 8

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcomes assessor will not be aware of participants' assignments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: July 11, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)