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Clinical Trials/NCT04933162
NCT04933162CompletedNot Applicable

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

Mayo Clinic2 sites in 1 country6 target enrollmentStarted: August 3, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Locations
2
Primary Endpoint
Decrease in endoscopic Mayo score for ulcerative colitis inflammation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Vulnerable adult
  • •Known bleeding disorders or takes medications that increase risk of bleeding from mucosal biopsies
  • •Use of oral antibiotic(s) within the past 4 weeks (can be enrolled after 4-week washout period)
  • •Use of commercial probiotic formulations and unwilling to stop for the duration of the study
  • •Diagnosis of diabetes
  • •Any other disease(s), condition(s) or habits(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes

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

Secondary Outcomes

  • Intestinal inflammation determined from blood and stool samples(8 weeks)
  • Urinary excretion of lactulose and 13C-Mannitol(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura E. Raffals, M.D

Principal Investigator

Mayo Clinic

Study Sites (2)

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