Synbiotic Treatment in Crohn's Disease Patients

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. Read our disclaimer for details. Identifier: NCT00305409
Recruitment Status : Completed
First Posted : March 21, 2006
Last Update Posted : February 11, 2009
Information provided by:
University of Dundee

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Synbiotic (Synergy I / B.longum) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Synbiotic Treatment in Crohn's Disease Patients
Study Start Date : June 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Primary Outcome Measures :
  1. Reduction in mucosal TNF-alpha

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

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
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

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 identifier (NCT number): 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

Publications: Identifier: NCT00305409     History of Changes
Other Study ID Numbers: CZB/4/335
RND ID: 2004GA07
LREC Ref: 05/51401/111
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009

Keywords provided by University of Dundee:

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases