Recruiting

Prebiotics

Sponsor:

UCLA

Code:

NCT06495658

Conditions

Crohn Disease

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Prebiotic

Study Details

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

Study ID

NCT06495658

Start date

Jul 9, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Prebiotic at Week 0

active comparator: Prebiotic at Week 8

Interventions

Prebiotic

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

Primary outcome measure

  • Clinical remission [ Time Frame: Week 8 ]
  • Change in fecal calprotectin [ Time Frame: Week 8 ]
  • Microbial composition [ Time Frame: Week 8 ]

Central Contacts and Locations

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Berkeley Limketkai, MD, PhD

8554238252berkeley.limketkai@gmail.com

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 27, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-02-27.