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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
United Kingdom
University of Glasgow
RECRUITING
Glasgow
Contact Information
Primary
Konstantinos Gerasimidis
Konstantinos.Gerasimidis@glasgow.ac.uk
+44 1419560580
Backup
Shona Mckirdy
s.mckirdy.1@research.gla.ac.uk
Time Frame
Start Date: 2024-05-08
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 36
Treatments
Experimental: Adults with quiescent Ulcerative Colitis
Adults with Ulcerative Colitis currently in remission (SCCAI ≤ 5)
Experimental: Healthy controls
Healthy adults (≥ 16y)
Sponsors
Leads: University of Glasgow

This content was sourced from clinicaltrials.gov

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