Memphis, Tennessee 38120


Purpose:

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.


Study summary:

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:


NCT ID:

NCT03594708


Primary Contact:

Principal Investigator
Randal K Buddington, PhD
The University of Memphis

Katie E Cook, BA
Phone: 612-804-5322
Email: kecook1@memphis.edu


Backup Contact:

Email: rbddngtn@memphis.edu
Randal K Buddington, PhD
Phone: 662-418-2666


Location Contact:

Memphis, Tennessee 38120
United States

Paul Bierman, MD
Phone: 901-761-3900
Email: Paul.Bierman@bmg.md

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.