Immunonutrition in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594708
• Other study ID #: UCS2018
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2018
• Source: Baptist Memorial Health Care Corporation
• Contact: Katie E Cook, BA
• Phone: 612-804-5322
• Email: kecook1[@]memphis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Dietary Supplement:
• Nutrition supplement
Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc
• Placebo supplement
rice starch, light olive oil, vegetable oil

Locations

Country	Name	City	State
United States	GI Specialists Foundation	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Memorial Health Care Corporation

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Rampertab S, Brown A. Inflammatory bowel disease. In: The Health Professional's Guide to Gastrointestinal Nutrition. Academy of Nutrition and Dietetics, 2015.

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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced inflammatory cytokines	cytokines will be isolated from blood analysis	2 months
Secondary	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.	2 months
Secondary	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	2 months
Secondary	Decreased intestinal cramping/ pain	Many with ulcerative colitis experience constant intestinal cramping. This intervention is geared towards reducing pain and discomfort for the participants	2 months