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UC Cohort - The Influence of Diet on Gut Microbiotas

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High Protein and Low Fiber Diet

Low Protein and High Fiber Diet

About this trial

This is an interventional supportive care trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High Protein and Low Fiber Group

Low Protein and High Fiber Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

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

Secondary Outcome Measures

Intestinal inflammation determined from blood and stool samples

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

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.

Full Information

NCT ID

NCT04933162

First Posted

June 15, 2021

Last Updated

July 21, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04933162

Brief Title

UC Cohort - The Influence of Diet on Gut Microbiotas

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 3, 2021 (Actual)

Primary Completion Date

February 17, 2023 (Actual)

Study Completion Date

February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Protein and Low Fiber Group

Arm Type

Experimental

Arm Description

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

Arm Title

Low Protein and High Fiber Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

High Protein and Low Fiber Diet

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Low Protein and High Fiber Diet

Intervention Description

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 Outcome Measure Information:

Title

Decrease in endoscopic Mayo score for ulcerative colitis inflammation

Description

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).

Time Frame

8 weeks

Title

Clinical remission derived from patient reported outcomes

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Intestinal inflammation determined from blood and stool samples

Description

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

Time Frame

8 weeks

Title

Urinary excretion of lactulose and 13C-Mannitol

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Raffals, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

UC Cohort - The Influence of Diet on Gut Microbiotas

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