Recruiting

Immunonutrition

Sponsor:

Baptist Memorial Health Care Corporation

Code:

NCT03594708

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nutrition supplement

Placebo supplement

Study Details

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.

Conditions

Ulcerative Colitis

Study ID

NCT03594708

Start date

Apr 30, 2018

Status verified date

Jul, 2018

Completion date

Dec 31, 2018

Anticipated

Primary completion date

Dec 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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

active comparator: Supplement

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

Interventions

Nutrition supplement

Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc

Placebo supplement

rice starch, light olive oil, vegetable oil

Primary outcome measure

  • Reduced inflammatory cytokines [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Katie E Cook, BA

612-804-5322kecook1@memphis.edu

Randal K Buddington, PhD

662-418-2666rbddngtn@memphis.edu

Locations

GI Specialists Foundation

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Paul Bierman, MD

901-761-3900Paul.Bierman@bmg.md

More Information

Sponsor

Baptist Memorial Health Care Corporation

Last update posted

Jul 20, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baptist Memorial Health Care Corporation on 2018-07-20.