UC Cohort - The Influence of Diet on Gut Microbiotas | NCT04933162

NCT04933162

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Protein and Low Fiber Group	Experimental	Subjects will consume a high protein and low fiber diet for 8 weeks	Dietary Supplement: High Protein and Low Fiber Diet
Low Protein and High Fiber Group	Experimental	Subjects will consume a low protein and high fiber diet for 8 weeks	Dietary Supplement: Low Protein and High Fiber Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Protein and Low Fiber Diet	Dietary Supplement	Protein intake will be increased to be >40% calories from protein, and the fiber intake will remain <15gm/day.	High Protein and Low Fiber Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 Outcomes

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

Eligibility Module

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

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747