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Microbiome-targeted Diet Therapy 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 and older
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 a new diet for adults with ulcerative colitis (UC), a disease that causes swelling and sores in the large bowel. The diet aims to meet higher protein needs while using fiber to lower the amount of hydrogen sulfide gas made by bacteria in the large bowel.

The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.

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

Eligibility

Who can join

  • Be at least 18 years old.
  • Be able and willing to give informed consent, meaning you understand and agree to join.
  • Have UC confirmed by a medical exam and a scope exam of the bowel.
  • Have had UC for at least 3 months.
  • Have a UCEIS score of 4 or less within 90 days before study group assignment. This score measures UC severity using a bowel scope exam.
  • Have no UC treatment or an unchanged treatment dose for the required time: at least 4 weeks for no medicine or 5-ASA medicines that reduce swelling; 8 weeks for medicines that change immune activity; or 12 weeks for biologic medicines that target the immune system. This rule does not cover steroids.
  • Be able to follow study requirements, as judged by the lead study doctor.

Who can't join

  • Have moderate or severe UC, with a bowel scope severity score of 5 or higher.
  • Have had stomach surgery or surgery to remove part of the bowel.
  • Have used antibiotics in the past 3 months, or expect to need them during the study.
  • Are pregnant or breastfeeding.
  • Have had a life-threatening food allergy reaction, or cannot tolerate a high-fiber diet.
  • Have ongoing alcohol or drug abuse.
  • Usually follow a vegan diet, eating no animal products.
  • Do not have enough freezer space for delivered meals.

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

Official eligibility criteria

Inclusion Criteria: * Ability and willingness to provide informed consent * Age at least 18 years old * Diagnosis of UC based on clinical and endoscopic criteria * UC duration of at least 3 months * Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization * On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below). 1. ≥4 weeks if no medication, 5-ASA 2. ≥8 wk for immunomodulatory therapy 3. ≥12 wk for biologics * Ability to comply with study requirements in the opinion of the primary investigator Exclusion Criteria: * Moderate or severe UC as defined by UCEIS ≥5 * History of stomach surgery or bowel resection * Antibiotic use within 3 months * Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics) * Pregnancy or breastfeeding * History of anaphylactic food allergies * Intolerance of high dietary fiber content * Ongoing alcohol or drug abuse * Habitual vegan diet pattern * Insufficient freezer space to accommodate meal delivery

Study sites (1)

MN