UC Cohort - The Influence of Diet on Gut Microbiotas

Not Applicable

Completed

• Conditions: Ulcerative Colitis
• Interventions: Dietary Supplement: High Protein and Low Fiber Diet; Dietary Supplement: Low Protein and High Fiber Diet

• Registration Number: NCT04933162
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-21
• Study Start: 2021-08-03
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Protein and Low Fiber Group	High Protein and Low Fiber Diet	Subjects will consume a high protein and low fiber diet for 8 weeks
Low Protein and High Fiber Group	Low Protein and High Fiber Diet	Subjects will consume a low protein and high fiber diet for 8 weeks

Primary Outcome Measures

Name	Time	Method
Decrease in endoscopic Mayo score for ulcerative colitis inflammation	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States