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NCT06998277Completed

Impact of the Novel UC-TREAT Diet on the Gut Microbiome and Its Acceptability in Healthy Adults and Adults With Quiescent Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 5 Mar 2026

Brief summary (registry, in English)

This will be an open-label dietary intervention study recruiting both healthy adults (≥16y) and adults with quiescent Ulcerative Colitis (UC). The study will span a total of 25 days and is divided into two phases; a 10-day run-in observation period (day -10 to day 0), during which the participant continues with their normal diet, and a 15-day dietary intervention period (day 0 to day 15), during which they will consume a diet high in specific high-fibre foods, fermented foods, berries, and a multivitamin-multimineral tablet. Throughout the study, participants will be asked to provide 3 blood samples (at days -10, 0, and 15), 4 stool and urine samples (at days -15, 0, 10, and 15), and to record a total of 6 days of food intake in provided food diaries. Disease activity, gastrointestinal symptoms, and quality of life will be assessed on 4 occasions (days -10, 0, 10, and 15) via validated questionnaires, and diet acceptability will be assessed at the end of the study.

Status (registry)
Completed
Study type
Interventional
Enrollment
36 (actual)
First submitted
9 May 2025
Start date
8 May 2024
Primary completion date
9 Jul 2025
Lead sponsor
University of Glasgow
NCT number
NCT06998277

What you commit to

  • Study type: Interventional
  • Participants enrolled: 36
  • From 8 May 2024 to the primary completion date, 9 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous surgery related to their UC (e.g. colectomy)
  • Adjustment of medication dose in the previous month
  • Initiation of a new medication in the prior 3 months
  • Antibiotics or steroid use in the past 2 months
  • Regular use of medication or regular visits to a physician
  • Antibiotics or steroid use in the past 2 months

Other illness

  • Self-reported active disease (SCCAI≥5) and/or a score ≥2 on any variable within SCCAI
  • History of gut surgery

Other

  • Individuals with Ulcerative Colitis:
  • BMI≥35kg/m2
  • Pregnancy or lactation
  • Regular use of pre/probiotic supplements
  • Weight fluctuations ≥ 2kg in the past month
  • Dietary restrictions (vegetarian, vegan, gluten-free etc)
  • Participation in other interventional research.
    • Healthy controls:
  • BMI≥35kg/m2
  • Pregnancy or lactation
  • Regular use of pre/probiotic supplements
  • Weight fluctuations ≥ 2kg in the past month
  • Dietary restrictions (vegetarian, vegan, gluten-free etc)
  • Participation in other interventional research.

Who the study is looking for

  • Individuals with Ulcerative Colitis:
  • Confirmed diagnosis of Ulcerative Colitis
  • ≥16 years of age
  • Motivated to follow the prescribed diet for the study period
    • Healthy controls:
  • ≥16 years of age
  • Motivated to follow the prescribed diet for the study period

Age in the registry: 16 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Glasgow
Coordinator of this site? Confirm its status
GlasgowUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.