RECRUITING

Impact of Prebiotics in Ulcerative Colitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis

Quick Facts

Study Start:2024-07-09
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06495658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18 to 85 years old
  2. * History of biopsy-proven ulcerative colitis (UC)
  3. * Active symptoms (SCCAI \>2)
  4. * 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.
  5. * Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.
  6. * Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial
  1. * Prior colectomy
  2. * Hospitalization
  3. * Urgent need for abdominal surgery
  4. * Unstable major medical condition
  5. * Active malignancy under treatment
  6. * Active alcohol or non-cannabinoid substance abuse
  7. * Pregnancy or lactation
  8. * Concerns for non-compliance

Contacts and Locations

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-09
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-07-09
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Crohn Disease
  • Ulcerative Colitis