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Clinical Trials/NCT00803829
NCT00803829CompletedNot Applicable

Synbiotic Treatment of Ulcerative Colitis Patients

University of Dundee2 sites in 1 country24 target enrollmentStarted: January 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
Reduction in mucosal TNF-alpha

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other

Study Sites (2)

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