Sustainable diet to shift gut microbes and lower ulcerative colitis activity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mount Sinai Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Jenny Lee
• Email: jenny.lee@sinaihealth.ca
• Phone: 4165864800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intestinal ultrasound-guided management for inflammatory bowel disease

  This study tests if adding point-of-care intestinal ultrasound at every visit changes treatment decisions for adults with Crohn’s disease or ulcerative colitis undergoing disease assessment.

  Recruiting Mahidol University · Bangkok · NCT07775352

• Aletekitug safety study in moderate to severe ulcerative colitis

  This sub-study tests whether aletekitug, an anti-IL-18 medication, is safe and tolerable for people with moderately to severely active ulcerative colitis.

  Recruiting Phase 1 GlaxoSmithKline · Oxford · NCT07747480

• Treatment study to test multiple interventions for moderate to severe ulcerative colitis

  This study tests whether a single master protocol can safely test the anti-IL-18 treatment Aletekitug (GSK1070806) in adults with moderate to severe ulcerative colitis to see if it is tolerable and potentially beneficial.

  Recruiting Phase 1 GlaxoSmithKline · Oxford · NCT07747467

• Characterization of Colorectal Dysplastic Lesions and Changes in Risk in IBD Patients

  This study tests how colorectal dysplastic lesions in adults with Crohn disease or ulcerative colitis change over time to help tailor screening and treatment.

  Recruiting at 2 sites Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Amiens and 1 other locations · NCT07719426

• Resting energy use in kids with inflammatory bowel disease

  This multicenter study will test the resting energy expenditure of children aged 6–17 with new IBD diagnoses to see how it relates to disease activity and treatment.

  Recruiting Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Alessandria, Piedmont · NCT07670975

• Guselkumab in Breast Milk for Lactating Women on Guselkumab

  This study tests how much guselkumab is present in the breast milk of lactating women who are already receiving guselkumab for their approved conditions.

  Recruiting Phase 4 Janssen Research & Development, LLC · Chapel Hill, North Carolina · NCT07654751

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.