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Synbiotic Treatment of Ulcerative Colitis Patients

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Synbiotic (Synergy1/B. longum)
Sponsored by
University of Dundee
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ninewells Hospital and Medical School

Outcomes

Primary Outcome Measures

Reduction in mucosal TNF-alpha

Secondary Outcome Measures

Induction of clinical remission measured by a reduction in Mayo disease activity score

Full Information

First Posted
December 5, 2008
Last Updated
July 5, 2011
Sponsor
University of Dundee
Collaborators
National Association for Colitis and Crohn's Disease
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1. Study Identification

Unique Protocol Identification Number
NCT00803829
Brief Title
Synbiotic Treatment of Ulcerative Colitis Patients
Official Title
Synbiotic Treatment of Ulcerative Colitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Dundee
Collaborators
National Association for Colitis and Crohn's Disease

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Synbiotic (Synergy1/B. longum)
Other Intervention Name(s)
prebiotic, probiotic
Intervention Description
Probiotic Bifidobacterium longum Prebiotic Synergy 1
Primary Outcome Measure Information:
Title
Reduction in mucosal TNF-alpha
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Induction of clinical remission measured by a reduction in Mayo disease activity score
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Macfarlane, PhD
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Macfarlane, PhD
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nigel Reynolds, BA(Hons) MBChB FRCP
Organizational Affiliation
Tayside University Hospitals Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Mowatt
Organizational Affiliation
Tayside University Hospital Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Dillon
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15227614
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.
Results Reference
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PubMed Identifier
15647189
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.
Results Reference
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PubMed Identifier
15016746
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.
Results Reference
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PubMed Identifier
14684582
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.
Results Reference
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PubMed Identifier
18383235
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.
Results Reference
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PubMed Identifier
18215222
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.
Results Reference
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Synbiotic Treatment of Ulcerative Colitis Patients

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