Impact of Prebiotics in Ulcerative Colitis

Recruiting · NCT06495658 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Los Angeles

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Crohn's disease Ulcerative Colitis

Interventions studied

Prebiotic

What this trial is about

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.

Who can take part

Age range

18 Years to 85 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

2 locations listed across 1 US state.

UCLA - Los Angeles, California, United States
UCLA - Los Angeles, California, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →