UC Cohort - The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas

Mayo Clinic1 site in 1 country6 target enrollmentAugust 3, 2021

ConditionsUlcerative Colitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ulcerative Colitis
Sponsor: Mayo Clinic
Enrollment: 6
Locations: 1
Primary Endpoint: Decrease in endoscopic Mayo score for ulcerative colitis inflammation
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to determine if different diets have different effects on the inflammation in the colon.

Registry

clinicaltrials.gov

Start Date

August 3, 2021

End Date

February 17, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Laura E. Raffals, M.D

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Adults ≥ 18 years old
•Ability to give informed consent
•Diagnosis of ulcerative colitis
•Moderate UC disease activity defined by a Mayo Score of \>6 with endoscopic score of 2
•On a baseline diet characterized by:
•Fiber intake of \< 15g/day
•\> 18% of daily calories from protein

Exclusion Criteria

•Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
•Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
•Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
•Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
•Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 2 weeks and for the duration of the study
•Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
•Unwilling to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
•Unwilling to stop stenuous exercise (running \>5 miles or equivalent) one week prior to the permeability tests
•Bowel preparation for colonoscopy less than one week prior to completion of the first stool kit and permeability test and flexible sigmoidoscopy and upper endoscopy
•Pregnancy or plan to become pregnant during the study time frame

Outcomes

Primary Outcomes

Decrease in endoscopic Mayo score for ulcerative colitis inflammation

Time Frame: 8 weeks

Measured from unprepped, non-sedated flexible sigmoidoscopy by decrease in Mayo score with a decrease of at least 1 point on the endoscopic subscore or absolute endoscopic subscore of 0-1).

Clinical remission derived from patient reported outcomes

Time Frame: 8 weeks

Defined as a Mayo score ≤2 and no sub-scores with a value greater than 1 is a secondary endpoint. This what the patient reports for stool frequency and reporting of any blood in the stool