Clinical trial NCT00803829: Synbiotic Treatment of Ulcerative Colitis Patients
Official title: Synbiotic Treatment of Ulcerative Colitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: National Association for Colitis and Crohn's Disease
First posted: 2008-12-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction in mucosal TNF-alpha
timeFrame: 6 months
Secondary outcomes:
measure: Induction of clinical remission measured by a reduction in Mayo disease activity score
timeFrame: 6 months
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Tayside
Study officials:
affiliation: University of Dundee
name: George Macfarlane, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dundee
name: Sandra Macfarlane, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tayside University Hospitals Trust
name: Nigel Reynolds, BA(Hons) MBChB FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Tayside University Hospital Trust
name: Craig Mowatt
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dundee
name: John Dillon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macfarlane S, Furrie E, Cummings JH, Macfarlane GT. Chemotaxonomic analysis of bacterial populations colonizing the rectal mucosa in patients with ulcerative colitis. Clin Infect Dis. 2004 Jun 15;38(12):1690-9. doi: 10.1086/420823. Epub 2004 May 25.
citation: Furrie E, Macfarlane S, Kennedy A, Cummings JH, Walsh SV, O'neil DA, Macfarlane GT. Synbiotic therapy (Bifidobacterium longum/Synergy 1) initiates resolution of inflammation in patients with active ulcerative colitis: a randomised controlled pilot trial. Gut. 2005 Feb;54(2):242-9. doi: 10.1136/gut.2004.044834.
citation: Fite A, Macfarlane GT, Cummings JH, Hopkins MJ, Kong SC, Furrie E, Macfarlane S. Identification and quantitation of mucosal and faecal desulfovibrios using real time polymerase chain reaction. Gut. 2004 Apr;53(4):523-9. doi: 10.1136/gut.2003.031245.
citation: Furrie E, Macfarlane S, Cummings JH, Macfarlane GT. Systemic antibodies towards mucosal bacteria in ulcerative colitis and Crohn's disease differentially activate the innate immune response. Gut. 2004 Jan;53(1):91-8. doi: 10.1136/gut.53.1.91.
citation: Steed H, Macfarlane GT, Macfarlane S. Prebiotics, synbiotics and inflammatory bowel disease. Mol Nutr Food Res. 2008 Aug;52(8):898-905. doi: 10.1002/mnfr.200700139.
citation: Macfarlane GT, Steed H, Macfarlane S. Bacterial metabolism and health-related effects of galacto-oligosaccharides and other prebiotics. J Appl Microbiol. 2008 Feb;104(2):305-44. doi: 10.1111/j.1365-2672.2007.03520.x.