Sustainable diet to shift gut microbes and lower ulcerative colitis activity

Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis

This project will try a sustainable non-elemental diet in adults with mild to moderately active ulcerative colitis to change gut bacteria and reduce disease activity.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Mount Sinai Hospital, Canada (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT04121806 on ClinicalTrials.gov

What this trial studies

Adults aged 18–75 with established mild to moderately active ulcerative colitis will follow a prescribed non-elemental UC intervention diet designed to modify the dysbiotic microbiome. Participants must have recent objective evidence of activity (Mayo score ≥2, fecal calprotectin >250, or active endoscopy) and maintain stable medical therapy during the intervention. Outcomes will include clinical disease activity, fecal biomarkers, and endoscopic findings to see whether the diet reduces inflammation. Key exclusions include uncontrolled inflammation likely to require surgery, pregnancy/lactation, PSC, NSAID use, or allergy/intolerance to core diet components.

Who should consider this trial

Good fit: Adults 18–75 with an established diagnosis of UC, mild to moderate disease activity (Mayo ≥2 or FCP >250 or recent active endoscopy), prior involvement >10 cm, and stable medical therapy are ideal candidates.

Not a fit: Patients with uncontrolled severe inflammation likely needing surgery soon, those with PSC, current NSAID use, pregnancy/lactation, or major allergies/intolerances to the diet components may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the diet could reduce intestinal inflammation and symptoms by shifting the gut microbiome, potentially lowering the need for medication escalation.

How similar studies have performed: There is supportive evidence that diet and microbiome changes can influence IBD, but no single adult UC diet is universally validated, so this specific non-elemental approach is relatively novel and unproven.

Eligibility criteria

Inclusion Criteria:

* • Females and Males between the ages of 18 - 75 years of age at the time of enrolment

  * Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria
  * Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment
  * Must have had \> 10cm involvement at some point in their disease history
  * FCP\>250 or active endo within 6 months
  * If a smoker, must not change smoking habits (frequency) during the course of the study
  * If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study

Exclusion Criteria:

* • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment

  * Pregnant or lactating females
  * Allergy or intolerance to key or a great number food components of the study diet
  * Current NSAID use
  * Diagnosed with PSC
  * Using topical therapies or suppositories
  * Antibiotic use within 4 weeks of the study enrollment or during the study
  * Confirmed C. difficile infection within 3 months of recruitment;
  * Diagnosis of primary PSC;
  * Currently using topical therapies or suppositories
  * History of dysplasia or colorectal neoplasia.

Where this trial is running

Toronto, Ontario

• Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Jenny Lee

Conditions Colitis, Ulcerative