Synbiotic Treatment in Crohn's Disease Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Synbiotic Treatment in Crohn's Disease Patients

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Synbiotic (Synergy I / B.longum)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Synbiotic (Synergy I / B.longum)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mucosal TNF-alpha |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's, TNF-alpha, Synbiotic, Probiotic