ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunonutrition in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03594708
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Katherine Cook, Baptist Memorial Health Care Corporation

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: Nutrition supplement Dietary Supplement: Placebo supplement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
placebo consisting of rice starch, light olive oil, and vegetable oil
Dietary Supplement: Placebo supplement
rice starch, light olive oil, vegetable oil

Active Comparator: Supplement
active supplement consisting of a fermentable fiber, omega-3 polyunsaturated fatty acid, vitamin D3, vitamin E, and zinc
Dietary Supplement: Nutrition supplement
Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc




Primary Outcome Measures :
  1. Reduced inflammatory cytokines [ Time Frame: 2 months ]
    cytokines will be isolated from blood analysis


Secondary Outcome Measures :
  1. Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts [ Time Frame: 2 months ]
    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.

  2. Reduced bowel movements per day [ Time Frame: 2 months ]
    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

  3. Decreased intestinal cramping/ pain [ Time Frame: 2 months ]
    Many with ulcerative colitis experience constant intestinal cramping. This intervention is geared towards reducing pain and discomfort for the participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594708


Contacts
Contact: Katie E Cook, BA 612-804-5322 kecook1@memphis.edu
Contact: Randal K Buddington, PhD 662-418-2666 rbddngtn@memphis.edu

Locations
United States, Tennessee
GI Specialists Foundation Recruiting
Memphis, Tennessee, United States, 38120
Contact: Paul Bierman, MD    901-761-3900    Paul.Bierman@bmg.md   
Sponsors and Collaborators
Baptist Memorial Health Care Corporation
Investigators
Principal Investigator: Randal K Buddington, PhD The University of Memphis

Publications:
Responsible Party: Katherine Cook, Research Assistant, Baptist Memorial Health Care Corporation
ClinicalTrials.gov Identifier: NCT03594708     History of Changes
Other Study ID Numbers: UCS2018
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vitamins
Vitamin D
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents