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Sponsors and Collaborators: |
University of Dundee National Association for Colitis and Crohn's Disease |
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Information provided by: | University of Dundee |
ClinicalTrials.gov Identifier: | NCT00803829 |
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 |
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Ulcerative Colitis |
Other: Synbiotic (Synergy1/B. longum) |
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 |
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) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr Sandra Macfarlane, PhD | 44 (0)1382 496341 | s.macfarlane@dundee.ac.uk |
United Kingdom, Tayside | |
Ninewells Hospital and Medical School | |
Dundee, Tayside, United Kingdom, DD1 9SY |
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 |
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 |
Digestive System Diseases Gastrointestinal Diseases Ulcer Sulfalene Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |