Impact of Prebiotics in Ulcerative Colitis

a study on Crohn's Disease Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Berkeley Limketkai, MD, PhD (ucla)

Description

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.

Official Title

The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis

Keywords

Crohn Disease, Ulcerative Colitis, Colitis, Ulcer, Prebiotic, Prebiotic at Week 0, Prebiotic at Week 8

Eligibility

You can join if…

Open to people ages 18-85

  • 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 CAN'T join 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

Location

  • UCLA accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06495658
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated