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Impact of Prebiotics in Ulcerative Colitis

The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how prebiotic supplements affect gut bacteria and gut health. It is for adults ages 18 to 85 with ulcerative colitis, a disease that causes swelling and sores in the large intestine, who have active symptoms. Participants are assigned by chance to take supplements for 8 weeks, starting at week 0 or week 8 of the 16-week study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 85 years old.
  • Have ulcerative colitis confirmed by a biopsy (a test of a small tissue sample).
  • Have active symptoms, with a symptom score called SCCAI above 2.
  • You may take 5-aminosalicylates, immune-system medicines called immunomodulators, or steroids if you have not started them or changed the dose in the past 30 days.
  • You may take biologic medicines if you have not started them or changed the dose in the past 60 days.
  • Past use of probiotics or other diet supplements is allowed, but you will be asked to stop them during the study.

Who can't join

  • Have had surgery to remove all or part of the large intestine.
  • Are in the hospital.
  • Need urgent belly surgery.
  • Have a serious health condition that is not stable.
  • Have active cancer that is being treated.
  • Currently misuse alcohol or drugs other than cannabis-related substances.
  • Are pregnant or breastfeeding.
  • The study team has concerns that you may not follow the study instructions.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA