NCT03594708

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

January 19, 2018

Last Update Submit

July 11, 2018

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Reduced inflammatory cytokines

    cytokines will be isolated from blood analysis

    2 months

Secondary Outcomes (3)

  • Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts

    2 months

  • Reduced bowel movements per day

    2 months

  • Decreased intestinal cramping/ pain

    2 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplement

Supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Nutrition supplement

Interventions

Nutrition supplementDIETARY_SUPPLEMENT

Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc

Supplement
Placebo supplementDIETARY_SUPPLEMENT

rice starch, light olive oil, vegetable oil

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GI Specialists Foundation

Memphis, Tennessee, 38120, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 18395894BACKGROUND

  • 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.

    PMID: 27793606BACKGROUND

  • 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.

    PMID: 27355913BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 15822041BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Randal K Buddington, PhD

    The University of Memphis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie E Cook, BA

CONTACT

612-804-5322kecook1@memphis.edu

Randal K Buddington, PhD

CONTACT

662-418-2666rbddngtn@memphis.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 19, 2018

First Posted

July 20, 2018

Study Start

April 30, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 20, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)