UC Cohort - The Influence of Diet on Gut Microbiotas

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933162
• Other study ID #: 20-012389
• Status: Completed
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: February 17, 2023

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Intestinal inflammation determined from blood and stool samples	Measures C-reactive protein from blood samples and fecal calprotectin from stool samples	8 weeks
Secondary	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

External Links

•   Mayo Clinic Clinical Trials