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

NCT06998277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-05

No results posted yet for this study

Summary

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.

Conditions

  • Ulcerative Colitis (UC)

Interventions

OTHER

Dietary therapy

Participants with quiescent UC will undergo a 10-day "observational" period followed by 15-days of the UC-TREAT dietary intervention. Disease activity, quality of life, and gastrointestinal symptoms will be assessed throughout

OTHER

Dietary therapy

Healthy participants will undergo a 10-day "observational" period, followed by 15-days of the UC-TREAT dietary intervention. Gastrointestinal symptoms will be assessed throughout.

Sponsors & Collaborators

  • University of Glasgow

    lead OTHER

Principal Investigators

  • Konstantinos Gerasimidis · University of Glasgow

  • Athanasios Koutsos · University of Glasgow

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-08
Primary Completion
2025-07-09
Completion
2025-07-09

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06998277 on ClinicalTrials.gov