Clinical trial NCT04933162: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Decrease in endoscopic Mayo score for ulcerative colitis inflammation
timeFrame: 8 weeks
measure: Clinical remission derived from patient reported outcomes
timeFrame: 8 weeks
Secondary outcomes:
measure: Intestinal inflammation determined from blood and stool samples
timeFrame: 8 weeks
measure: Urinary excretion of lactulose and 13C-Mannitol
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Laura Raffals, MD
role: PRINCIPAL_INVESTIGATOR
References: