UC Cohort - The Influence of Diet on Gut Microbiotas

NCT04933162 | Completed

• 1 other identifier: 20-012389
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Decrease in endoscopic Mayo score for ulcerative colitis inflammation

  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).

  8 weeks

• Clinical remission derived from patient reported outcomes

  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

  8 weeks

Secondary Outcomes (2)

• Intestinal inflammation determined from blood and stool samples

  8 weeks

• Urinary excretion of lactulose and 13C-Mannitol

  8 weeks

Study Arms (2)

High Protein and Low Fiber Group

EXPERIMENTAL

Subjects will consume a high protein and low fiber diet for 8 weeks

Dietary Supplement: High Protein and Low Fiber Diet

Low Protein and High Fiber Group

EXPERIMENTAL

Subjects will consume a low protein and high fiber diet for 8 weeks

Dietary Supplement: Low Protein and High Fiber Diet

Interventions

High Protein and Low Fiber Diet DIETARY_SUPPLEMENT

Protein intake will be increased to be \>40% calories from protein, and the fiber intake will remain \<15gm/day.

High Protein and Low Fiber Group

Low Protein and High Fiber Diet DIETARY_SUPPLEMENT

Increase fiber intake up to 40gms of fiber with a requirement to increase at least 15gms above baseline fiber, with 50-75% of total fiber intake from psyllium husk. Subjects will be allowed to slowly increase fiber every two days to reach goal by end of week 1. The total protein will be reduced to \<10% total calories from protein.

Low Protein and High Fiber Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Laura Raffals, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 21, 2021
• Study Start: August 3, 2021
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

US (1)