Synbiotic Treatment in Crohn's Disease Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Synbiotic Treatment in Crohn's Disease Patients|
- Reduction in mucosal TNF-alpha
- 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.
|Study Start Date:||June 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305409
|Dundee University, Dept of Pathology and Neuroscience|
|Dundee, Angus, United Kingdom, DD1 9SY|
|Ninewells Hospital and Medical School|
|Dundee, Tayside, United Kingdom, DD1 9SY|
|Principal Investigator:||George MacFarlane, BSc PhD||University of Dundee|