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Clinical Trials/NCT00803829
NCT00803829
Completed
Not Applicable

Synbiotic Treatment of Ulcerative Colitis Patients

University of Dundee1 site in 1 country24 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ulcerative Colitis
Sponsor
University of Dundee
Enrollment
24
Locations
1
Primary Endpoint
Reduction in mucosal TNF-alpha
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
January 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Reduction in mucosal TNF-alpha

Time Frame: 6 months

Secondary Outcomes

  • Induction of clinical remission measured by a reduction in Mayo disease activity score(6 months)

Study Sites (1)

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