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Immunonutrition in Ulcerative Colitis

Not Applicable
Conditions
Ulcerative Colitis
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.

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
Primary Outcome Measures
NameTimeMethod
Reduced inflammatory cytokines2 months

cytokines will be isolated from blood analysis

Secondary Outcome Measures
NameTimeMethod
Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts2 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 day2 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/ pain2 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

GI Specialists Foundation
🇺🇸Memphis, Tennessee, United States
Paul Bierman, MD
Contact
901-761-3900
Paul.Bierman@bmg.md

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