Synbiotic Treatment in Crohn's Disease Patients

Last updated: February 10, 2009
Sponsor: University of Dundee
Overall Status: Completed

Phase

N/A

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT00305409
CZB/4/335
LREC Ref: 05/51401/111
RND ID: 2004GA07
  • Ages 18-79
  • All Genders

Study Summary

The purpose of this study is to determine whether administration of a synbiotic, comprised on inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to reduce mucosal inflammation and induce remission.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Crohn's disease of large bowel (+/- small bowel disease)

  • 18-79 years old

  • stable doses of medications

  • CDAI >150, <450

Exclusion

Exclusion Criteria:

  • short gut syndrome

  • pregnancy

  • lactation

  • antibiotic therapy in last 3 months

  • probiotic therapy in last 1 month

  • <18, >79 years old

  • CDAI <150 or >450

  • indeterminate colitis, ulcerative colitis

  • alterations to medications in last 3 months

Study Design

Total Participants: 50
Study Start date:
June 01, 2006
Estimated Completion Date:
December 31, 2008

Study Description

Crohn's disease is one of the two main forms of idiopathic inflammatory bowel disease. The Th1-mediated inflammatory response in Crohn's disease is characterised by increased IL-18 and INF-gamma and especially TNF-alpha, which are formed by lamina propria mononuclear cells. The aim of this investigation is to determine whether a synbiotic comprised of inulin and a bifidobacterial probiotic, that we have previously shown to down-regulate TNF-alpha and other proinflammatory cytokines in the gut mucosa in ulcerative colitis patients with active disease, can colonise the bowel wall, reduce mucosal inflammation and induce remission in Crohn's disease patients with active disease, in a randomised controlled trial. Crohn's disease is associated with high mortality and incurs significant social, commercial and NHS costs. Many patients are refractile to standard treatments, which often have undesirable side effects. An inexpensive, effective and non-toxic treatment based on the synbiotic concept would contribute greatly to relieving the clinical and financial burdens of the disease.

Connect with a study center

  • Dundee University, Dept of Pathology and Neuroscience

    Dundee, Angus DD1 9SY
    United Kingdom

    Site Not Available

  • Ninewells Hospital and Medical School

    Dundee, Tayside DD1 9SY
    United Kingdom

    Site Not Available

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