Synbiotic Treatment in Crohn's Disease Patients

Not Applicable

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT00305409
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-21
• Study Start: 2006-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-10
• Last Update Posted: 2009-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in mucosal TNF-alpha

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Dundee University, Dept of Pathology and Neuroscience; 🇬🇧 Dundee, Angus, United Kingdom

Ninewells Hospital and Medical School; 🇬🇧 Dundee, Tayside, United Kingdom