Immunonutrition in Ulcerative Colitis

Baptist Memorial Health Care Corporation

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Dietary Supplement: Nutrition supplement; Dietary Supplement: Placebo supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03594708

UCS2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo consisting of rice starch, light olive oil, and vegetable oil

Treatment:

Dietary Supplement: Placebo supplement

Supplement

Active Comparator group

Description:

active supplement consisting of a fermentable fiber, omega-3 polyunsaturated fatty acid, vitamin D3, vitamin E, and zinc

Treatment:

Dietary Supplement: Nutrition supplement