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Synbiotic Treatment in Crohn's Disease Patients

This study has been completed.
Information provided by:
University of Dundee Identifier:
First received: March 20, 2006
Last updated: February 10, 2009
Last verified: February 2009
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.

Condition Intervention
Crohn's Disease Drug: Synbiotic (Synergy I / B.longum)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Synbiotic Treatment in Crohn's Disease Patients

Resource links provided by NLM:

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Reduction in mucosal TNF-alpha

Secondary Outcome Measures:
  • Number of patients in remission as assessed by CDAI.
  • Significant differences in mucosal regeneration between pre-synbiotic and post-synbiotic therapy groups and pre-control and post-control therapy groups.
  • Differences in TNF-alpha, IL-18 and INF-gamma between the post-synbiotic and post-control groups.

Estimated Enrollment: 50
Study Start Date: June 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed 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.

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Crohn's disease of large bowel (+/- small bowel disease)
  • 18-79 years old
  • stable doses of medications
  • CDAI >150, <450

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00305409

United Kingdom
Dundee University, Dept of Pathology and Neuroscience
Dundee, Angus, United Kingdom, DD1 9SY
Ninewells Hospital and Medical School
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Principal Investigator: George MacFarlane, BSc PhD University of Dundee
  More Information

Publications: Identifier: NCT00305409     History of Changes
Other Study ID Numbers: CZB/4/335
RND ID: 2004GA07
LREC Ref: 05/51401/111
Study First Received: March 20, 2006
Last Updated: February 10, 2009

Keywords provided by University of Dundee:

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on September 21, 2017