Synbiotic Treatment of Ulcerative Colitis Patients

Study Overview
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Brief Summary
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Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is associated with high morbidity and incurs significant social, commercial and NHS costs. For a variety of reasons, many patients are refractile to standard therapies, which often have undesirable side-effects. However, an inexpensive and non-toxic treatment based on the synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a food source for the probiotic, allowing it to grow better in the gut. The aim of this study is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with active disease. It is planned to establish a double-blinded, controlled, randomised investigation involving 46 patients for six months. If the results from our pilot study can be reproduced and maintained in a long-term investigation, the synbiotic could become available very quickly, and would provide an inexpensive and effective treatment for UC, making a significant contribution to relieving the clinical and financial burdens of this disease.

Official Title
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Synbiotic Treatment of Ulcerative Colitis Patients

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Synbiotic (Synergy1/B. longum)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ulcerative colitis Stable doses of medications for UC for the preceding three months Mayo score of 6 to 12 Sigmoidoscopy subscore of 2 Stable doses of medication Exclusion Criteria: Pregnancy Lactation Antibiotic therapy in the last three months Probiotic or prebiotic therapy in the last month Crohn's Disease, indeterminate colitis Alterations to medications in the last three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Synbiotic (Synergy1/B. longum)|Probiotic Bifidobacterium longum Prebiotic Synergy 1|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mucosal TNF-alpha |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of clinical remission measured by a reduction in Mayo disease activity score |  | 6 months |