Synbiotic Treatment in Crohn's Disease Patients

This study has been completed.
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00305409
First received: March 20, 2006
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305409

Locations
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
Investigators
Principal Investigator: George MacFarlane, BSc PhD University of Dundee
  More Information

Publications:

ClinicalTrials.gov 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
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Dundee:
Crohn's
TNF-alpha
Synbiotic
Probiotic

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

ClinicalTrials.gov processed this record on April 17, 2014