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Sponsored by: |
University of Dundee |
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Information provided by: | University of Dundee |
ClinicalTrials.gov Identifier: | NCT00305409 |
To determine whether administration of a synbiotic, comprised on inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to reduce mucosal inflammation and induce remission.
Condition | Intervention |
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Crohn's Disease |
Drug: Synbiotic (Synergy I / B.longum) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Synbiotic Treatment in Crohn's Disease Patients |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2007 |
Crohn's disease is one of the two main forms of idiopathic inflammatory bowel disease. The Th1-mediated inflammatory response in Crohn's disease is characterised by increased IL-18 and INF-gamma and especially TNF-alpha, which are formed by lamina propria mononuclear cells. The aim of this investigation is to determine whether a synbiotic comprised of inulin and a bifidobacterial probiotic, that we have previously shown to down-regulate TNF-alpha and other proinflammatory cytokines in the gut mucosa in ulcerative colitis patients with active disease, can colonise the bowel wall, reduce mucosal inflammation and induce remission in Crohn's disease patients with active disease, in a randomised controlled trial. Crohn's disease is associated with high mortality and incurs significant social, commercial and NHS costs. Many patients are refractile to standard treatments, which often have undesirable side effects. An inexpensive, effective and non-toxic treatment based on the synbiotic concept would contribute greatly to relieving the clinical and financial burdens of the disease.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Helen D Steed, MBChB, MRCP | 01382 496341 | helensteed@doctors.org.uk |
Contact: Sandra Macfarlane, BSC, PhD | 01382 632535 | s.macfarlane@dundee.ac.uk |
United Kingdom, Angus | |
Dundee University, Dept of Pathology and Neuroscience | Recruiting |
Dundee, Angus, United Kingdom, DD1 9SY | |
Contact: Sandra Macfarlane, BSc PhD 01382 496341 s.macfarlane@dundee.ac.uk | |
Principal Investigator: Sandra Macfarlane, BSc PhD | |
Principal Investigator: Helen D Steed, MBChB MRCP | |
United Kingdom, Tayside | |
Ninewells Hospital and Medical School | Recruiting |
Dundee, Tayside, United Kingdom, DD1 9SY | |
Contact: Nigel Reynolds, BA(Hons) MBChB FRCP 01382 660111 nigel.reynolds@tuht.scot.nhs.uk | |
Principal Investigator: Helen D Steed, MBChB MRCP | |
Principal Investigator: John H Cummings, MBChB MSc MA FRCP R Nutr | |
Principal Investigator: Nigel Reynolds, BA(Hons) MBChB FRCP |
Principal Investigator: | George MacFarlane, BSc PhD | University of Dundee |
Study ID Numbers: | CZB/4/335, RND ID: 2004GA07, LREC Ref: 05/51401/111 |
Study First Received: | March 20, 2006 |
Last Updated: | September 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00305409 |
Health Authority: | United Kingdom: National Health Service |
Crohn's TNF-alpha Synbiotic Probiotic |
Digestive System Diseases Gastrointestinal Diseases Sulfalene Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |