Immunonutrition in Ulcerative Colitis

Not Applicable

• Conditions: Ulcerative Colitis
• Interventions: Dietary Supplement: Placebo supplement; Dietary Supplement: Nutrition supplement

• Registration Number: NCT03594708
• Lead Sponsor: Baptist Memorial Health Care Corporation

Brief Summary

This study tests the hypothesis that a supplement that combines a functional fiber, long chain omega-3 polyunsaturated fatty acids (PUFAs), vitamin D3, vitamin E, and zinc will reduce clinical symptoms, decrease pro-inflammatory cytokines in the blood and ergo decrease inflammation, promote beneficial microbial activity in the colon, and help recovery of the intestinal mucosa of ulcerative colitis (UC) patients compared with a placebo.

Detailed Description

An anticipated 30 participants with newly diagnosed active ulcerative colitis will be recruited to participate in a randomized control trial, with 50% of the subjects distributed to the supplement (n=15) and the other 50% provided a placebo control (n=15). This is considered as a "proof of concept" study to determine if there is evidence that a multi-ingredient supplement (immunonutrition) will reduce UC disease severity.

Study Timeline

• Study First Submitted: 2018-01-19
• Study Start: 2018-04-30
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-11
• Last Update Submitted: 2018-07-11
• Study First Posted: 2018-07-20
• Last Update Posted: 2018-07-20
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients with active ulcerative colitis (proof of diagnosis from gastroenterologist), over 18 years old, has over 50% gut remaining, fully connected bowels (no colostomy), currently on 5-aminosalicylates (ASA) drugs, not pregnant or lactating

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo supplement	placebo consisting of rice starch, light olive oil, and vegetable oil
Supplement	Nutrition supplement	active supplement consisting of a fermentable fiber, omega-3 polyunsaturated fatty acid, vitamin D3, vitamin E, and zinc

Primary Outcome Measures

Name	Time	Method
Reduced inflammatory cytokines	2 months	cytokines will be isolated from blood analysis

Secondary Outcome Measures

Name	Time	Method
Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts	2 months	SCFA will be isolated from stool sample. SCFAs are anti-inflammatory components generated in the colon. The SCFAs looked at include acetate, lactate, propionate, butyrate, and isobutyrate.
Reduced bowel movements per day	2 months	Many with Ulcerative colitis can experience 10+ bowel movements per day. This intervention is aiming to reduce the total number of bowel movements per day
Decreased intestinal cramping/ pain	2 months	Many with ulcerative colitis experience constant intestinal cramping. This intervention is geared towards reducing pain and discomfort for the participants

Trial Locations

Locations (1)

GI Specialists Foundation; 🇺🇸 Memphis, Tennessee, United States