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Dietary Supplement
Immunonutrition in Ulcerative Colitis
N/A
Waitlist Available
Led By Randal K Buddington, PhD
Research Sponsored by Baptist Memorial Health Care Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
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.
Eligible Conditions
- Colitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduced inflammatory cytokines
Secondary study objectives
Decreased intestinal cramping/ pain
Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts
Reduced bowel movements per day
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: SupplementActive Control1 Intervention
active supplement consisting of a fermentable fiber, omega-3 polyunsaturated fatty acid, vitamin D3, vitamin E, and zinc
Group II: PlaceboPlacebo Group1 Intervention
placebo consisting of rice starch, light olive oil, and vegetable oil
Find a Location
Who is running the clinical trial?
Baptist Memorial Health Care CorporationLead Sponsor
5 Previous Clinical Trials
28,721 Total Patients Enrolled
Randal K Buddington, PhDPrincipal InvestigatorThe University of Memphis