NCT00305409

Synbiotic Treatment in Crohn's Disease Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Dundee · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Synbiotic (Synergy I / B.longum)

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-03-21
• Last updated: 2009-02-11

Locations

2 sites across 1 country: United Kingdom