Synbiotic Treatment of Ulcerative Colitis Patients

NCT ID: NCT00803829

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-01-31

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

Synbiotic (Synergy1/B. longum)

Probiotic Bifidobacterium longum Prebiotic Synergy 1

Intervention Type: OTHER

Other Intervention Names

prebiotic; probiotic

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Association for Colitis and Crohn's Disease

OTHER

Sponsor Role: collaborator

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

University of Dundee

Principal Investigators

George Macfarlane, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Sandra Macfarlane, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Nigel Reynolds, BA(Hons) MBChB FRCP

Role: PRINCIPAL_INVESTIGATOR

Tayside University Hospitals Trust

Craig Mowatt

Role: PRINCIPAL_INVESTIGATOR

Tayside University Hospital Trust

John Dillon

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

Ninewells Hospital and Medical School

Dundee, Tayside, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 15227614 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15647189 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15016746 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14684582 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18383235 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18215222 (View on PubMed)

Other Identifiers

NACC: M/08/2

Identifier Type: -

Identifier Source: secondary_id

REC: 08/S1402/45

Identifier Type: -

Identifier Source: secondary_id

RD: 2007GA08

Identifier Type: -

Identifier Source: secondary_id

20509

Identifier Type: -

Identifier Source: org_study_id