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Completed

NCT Number: NCT04933162

UC Cohort - The Influence of Diet on Gut Microbiotas

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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

  1. Intestinal inflammation determined from blood and stool samples

    Time frame: 8 weeks

    Measures C-reactive protein from blood samples and fecal calprotectin from stool samples

  2. Urinary excretion of lactulose and 13C-Mannitol

    Time frame: 8 weeks

    Small Bowel and Colonic Permeability by Urinary Excretion of Lactulose and 13C-Mannitol after Oral Ingestion of lactulose and 13C mannitol (5:1 ratio by mass). The 0-2h urine most closely reflects small intestinal permeability and 8-24h urine reflects colonic permeability. HPLC-tandem mass spectrometry will be used for detection of the sugars. The results will be expressed as the ratio of percentage excretion of the ingested dose of lactulose and mannitol in urine.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2021
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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