Immunonutrition in Ulcerative Colitis
Clinical Trial ID: NCT03594708
Description
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.
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.
Criteria
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: -
Start Date
2018-04-30
Last Updated
2018-07-11
Sponsor
Baptist Memorial Health Care Corporation
Condition Name
Ulcerative Colitis
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