UC Cohort - The Influence of Diet on Gut Microbiotas

Mayo Clinic

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Dietary Supplement: High Protein and Low Fiber Diet; Dietary Supplement: Low Protein and High Fiber Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04933162

20-012389

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups

High Protein and Low Fiber Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: High Protein and Low Fiber Diet

Low Protein and High Fiber Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Low Protein and High Fiber Diet