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Synbiotic Treatment of Ulcerative Colitis Patients
This study is not yet open for participant recruitment.
Verified by University of Dundee, November 2008
Sponsors and Collaborators: University of Dundee
National Association for Colitis and Crohn's Disease
Information provided by: University of Dundee
ClinicalTrials.gov Identifier: NCT00803829
  Purpose

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.


Condition Intervention
Ulcerative Colitis
Other: Synbiotic (Synergy1/B. longum)

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Ulcerative Colitis
Drug Information available for: Sulfalene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Synbiotic Treatment of Ulcerative Colitis Patients

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Reduction in mucosal TNF-alpha [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Induction of clinical remission measured by a reduction in Mayo disease activity score [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: January 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803829

Contacts
Contact: Dr Sandra Macfarlane, PhD 44 (0)1382 496341 s.macfarlane@dundee.ac.uk

Locations
United Kingdom, Tayside
Ninewells Hospital and Medical School
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
National Association for Colitis and Crohn's Disease
Investigators
Principal Investigator: George Macfarlane, PhD University of Dundee
Principal Investigator: Sandra Macfarlane, PhD University of Dundee
Principal Investigator: Nigel Reynolds, BA(Hons) MBChB FRCP Tayside University Hospitals Trust
Principal Investigator: Craig Mowatt Tayside University Hospital Trust
Principal Investigator: John Dillon University of Dundee
  More Information

Publications:
Responsible Party: University of Dundee ( Professor George Macfarlane )
Study ID Numbers: 20509, NACC: M/08/2, REC: 08/S1402/45, RD: 2007GA08
Study First Received: December 5, 2008
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00803829  
Health Authority: United Kingdom: Research Ethics Committee

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Sulfalene
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009