Ulcerative ColitisNCT00803829
Synbiotic Treatment of Ulcerative Colitis Patients
A study testing Synbiotic (Synergy1/B. longum) in people with Ulcerative Colitis, run by University of Dundee at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Synbiotic (Synergy1/B. longum)
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ninewells Hospital and Medical School
Dundee, Tayside, DD1 9SY
About this study
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
- Being tested
- Synbiotic (Synergy1/B. longum)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic (Synergy1/B. longum)Other
Also called prebiotic, probiotic
Probiotic Bifidobacterium longum Prebiotic Synergy 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mucosal TNF-alpha
Measured: 6 months
Secondary outcomes (1)
Induction of clinical remission measured by a reduction in Mayo disease activity score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- National Association for Colitis and Crohn's Disease
- Investigators
- George Macfarlane, PhD, Principal investigator, University of DundeeSandra Macfarlane, PhD, Principal investigator, University of DundeeNigel Reynolds, BA(Hons) MBChB FRCP, Principal investigator, Tayside University Hospitals TrustCraig Mowatt, Principal investigator, Tayside University Hospital TrustJohn Dillon, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803829
- Sponsor's protocol ID
- 20509
- Other IDs
- NACC: M/08/2, REC: 08/S1402/45, RD: 2007GA08
- Status last verified
- Jul 2011
- First submitted
- 5 Dec 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15227614Furrie 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.
PubMed 15647189Fite 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.
PubMed 15016746Furrie 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.
PubMed 14684582Steed 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.
PubMed 18383235Macfarlane 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.
PubMed 18215222
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synbiotic Treatment of Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT00803829
- Acronym / sponsor ID
- 20509
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- National Association for Colitis and Crohn's Disease
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Lactation
- Antibiotic therapy in the last three months
- Probiotic or prebiotic therapy in the last month
- Crohn's Disease, indeterminate colitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotic (Synergy1/B. longum)Also: prebiotic, probioticProbiotic Bifidobacterium longum Prebiotic Synergy 1 | Other | – |
Primary outcome
Reduction in mucosal TNF-alpha
Time frame: 6 months
1 secondary outcome
Induction of clinical remission measured by a reduction in Mayo disease activity score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
- Background: PubMed 15227614Macfarlane 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.
- Background: PubMed 15647189Furrie 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.
- Background: PubMed 15016746Fite 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.
- Background: PubMed 14684582Furrie 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.
- Background: PubMed 18383235Steed 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.
- Background: PubMed 18215222Macfarlane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Macfarlane, PhD principal investigator
University of Dundee
Sandra Macfarlane, PhD principal investigator
University of Dundee
Nigel Reynolds, BA(Hons) MBChB FRCP principal investigator
Tayside University Hospitals Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic (Synergy1/B. longum) in people with Ulcerative Colitis, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in mucosal TNF-alpha (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803829, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.