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Immunonutrition in Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition supplement
Placebo supplement
Sponsored by
Baptist Memorial Health Care Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

-

Sites / Locations

  • GI Specialists FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Supplement

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduced inflammatory cytokines
cytokines will be isolated from blood analysis

Secondary Outcome Measures

Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts
SCFA will be isolated from stool sample. SCFAs are anti-inflammatory components generated in the colon. The SCFAs looked at include acetate, lactate, propionate, butyrate, and isobutyrate.
Reduced bowel movements per day
Many with Ulcerative colitis can experience 10+ bowel movements per day. This intervention is aiming to reduce the total number of bowel movements per day
Decreased intestinal cramping/ pain
Many with ulcerative colitis experience constant intestinal cramping. This intervention is geared towards reducing pain and discomfort for the participants

Full Information

First Posted
January 19, 2018
Last Updated
July 11, 2018
Sponsor
Baptist Memorial Health Care Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03594708
Brief Title
Immunonutrition in Ulcerative Colitis
Official Title
Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baptist Memorial Health Care Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo consisting of rice starch, light olive oil, and vegetable oil
Arm Title
Supplement
Arm Type
Active Comparator
Arm Description
active supplement consisting of a fermentable fiber, omega-3 polyunsaturated fatty acid, vitamin D3, vitamin E, and zinc
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition supplement
Intervention Description
Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplement
Intervention Description
rice starch, light olive oil, vegetable oil
Primary Outcome Measure Information:
Title
Reduced inflammatory cytokines
Description
cytokines will be isolated from blood analysis
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts
Description
SCFA will be isolated from stool sample. SCFAs are anti-inflammatory components generated in the colon. The SCFAs looked at include acetate, lactate, propionate, butyrate, and isobutyrate.
Time Frame
2 months
Title
Reduced bowel movements per day
Description
Many with Ulcerative colitis can experience 10+ bowel movements per day. This intervention is aiming to reduce the total number of bowel movements per day
Time Frame
2 months
Title
Decreased intestinal cramping/ pain
Description
Many with ulcerative colitis experience constant intestinal cramping. This intervention is geared towards reducing pain and discomfort for the participants
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie E Cook, BA
Phone
612-804-5322
Email
kecook1@memphis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Randal K Buddington, PhD
Phone
662-418-2666
Email
rbddngtn@memphis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal K Buddington, PhD
Organizational Affiliation
The University of Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
GI Specialists Foundation
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Bierman, MD
Phone
901-761-3900
Email
Paul.Bierman@bmg.md

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18395894
Citation
Torres MI, Rios A. Current view of the immunopathogenesis in inflammatory bowel disease and its implications for therapy. World J Gastroenterol. 2008 Apr 7;14(13):1972-80. doi: 10.3748/wjg.14.1972.
Results Reference
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PubMed Identifier
27793606
Citation
Lewis JD, Abreu MT. Diet as a Trigger or Therapy for Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):398-414.e6. doi: 10.1053/j.gastro.2016.10.019. Epub 2016 Oct 25.
Results Reference
background
PubMed Identifier
27355913
Citation
Ruemmele FM. Role of Diet in Inflammatory Bowel Disease. Ann Nutr Metab. 2016;68 Suppl 1:33-41. doi: 10.1159/000445392. Epub 2016 Jun 30.
Results Reference
background
Citation
Rampertab S, Brown A. Inflammatory bowel disease. In: The Health Professional's Guide to Gastrointestinal Nutrition. Academy of Nutrition and Dietetics, 2015.
Results Reference
background
PubMed Identifier
15822041
Citation
Seidner DL, Lashner BA, Brzezinski A, Banks PL, Goldblum J, Fiocchi C, Katz J, Lichtenstein GR, Anton PA, Kam LY, Garleb KA, Demichele SJ. An oral supplement enriched with fish oil, soluble fiber, and antioxidants for corticosteroid sparing in ulcerative colitis: a randomized, controlled trial. Clin Gastroenterol Hepatol. 2005 Apr;3(4):358-69. doi: 10.1016/s1542-3565(04)00672-x.
Results Reference
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Immunonutrition in Ulcerative Colitis

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