UC Cohort - The Influence of Diet on Gut Microbiotas

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

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Dietary supplement: High Protein and Low Fiber Diet; Dietary supplement: Low Protein and High Fiber Diet

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults ≥ 18 years old
2. Ability to give informed consent
3. Diagnosis of ulcerative colitis
4. Moderate UC disease activity defined by a Mayo Score of >6 with endoscopic score of 2

5. On a baseline diet characterized by:

   • Fiber intake of < 15g/day
   • > 18% of daily calories from protein

Exclusion Criteria:

1. Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
2. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
3. 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
4. Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
5. 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
6. Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
7. 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
8. Unwilling to stop stenuous exercise (running >5 miles or equivalent) one week prior to the permeability tests
9. 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
10. Pregnancy or plan to become pregnant during the study time frame
11. Vulnerable adult
12. Known bleeding disorders or takes medications that increase risk of bleeding from mucosal biopsies
13. Use of oral antibiotic(s) within the past 4 weeks (can be enrolled after 4-week washout period)
14. Use of commercial probiotic formulations and unwilling to stop for the duration of the study
15. Diagnosis of diabetes
16. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Protein and Low Fiber Group; Subjects will consume a high protein and low fiber diet for 8 weeks	Dietary supplement: High Protein and Low Fiber Diet; Protein intake will be increased to be >40% calories from protein, and the fiber intake will remain <15gm/day.
Experimental: Low Protein and High Fiber Group; Subjects will consume a low protein and high fiber diet for 8 weeks	Dietary supplement: Low Protein and High Fiber Diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal inflammation determined from blood and stool samples	Measures C-reactive protein from blood samples and fecal calprotectin from stool samples	8 weeks
Urinary excretion of lactulose and 13C-Mannitol	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.	8 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Laura Raffals, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 20-012389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No