AgingNCT01226212
Can Synbiotic Use Effect Gut Bacteria and the Immune Response in Older People
A study testing Synbiotic (Synergy 1/B. longum) in people with Aging, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The objectives of this study are to use a nutritional change in the diet to improve gut health in older people. Ageing can result in major changes in the composition and activities of the bacteria in your gut, leading to a higher incidence of gastrointestinal infections, decreased intestinal motility and impaired… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Synbiotic (Synergy 1/B. longum)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Dec 2012
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-90 years
- BMI 18.5-30.0 kg m2.
Who cannot join
- asplenia and other acquired or congenital immunodeficiencies
- any autoimmune disease
- connective tissue diseases
- self-reported symptoms of acute or recent infection (including use of antibiotics within the previous 3 months)
- taking probiotics or prebiotics, including lactulose for constipation
- chronic gastrointestinal problems (e.g. Inflammatory bowel disease, irritable bowel syndrome, cancer)
- use of immunosuppressive or anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Oncology and Molecular Medicine, Ninewells Hospital and Medical School
Dundee, Tayside, DD1 9SY
About this study
Official title: Can Synbiotic Use Improve Dysbiosis in the Gut Microbiome and Modify Inflammatory Processes in Older People
The objectives of this study are to use a nutritional change in the diet to improve gut health in older people. Ageing can result in major changes in the composition and activities of the bacteria in your gut, leading to a higher incidence of gastrointestinal infections, decreased intestinal motility and impaired bowel function as people get older. This can result in constipation or diarrhoea, increased levels of inflammation and reduced immune response to infection. Therefore, individuals aged 65 or over could benefit from safe and effective interventions that maintain a healthy balance of gut bacteria as well as restoring the immune response. Bacteria in the gut are known to promote health. Eating foods containing beneficial bacteria for example (probiotics) or food which contain substrates for the bacteria to grow on (prebiotics) can improve the balance of gut bacteria. The investigators will use a synbiotic with known anti-inflammatory properties, comprising a probiotic Bifidobacterium longum strain and inulin (Synergy 1), The synbiotic has been previously shown to be beneficial in reducing inflammation and to increase levels of beneficial bacteria in the gut in two studies in patients with inflammatory bowel disease. The investigators would now for these reasons, like to determine the effects of our Synbiotic on the gut bacteria and immune function of older individuals in a double-blinded, crossover, placebo controlled, randomised investigation involving 40 volunteers for three months. The trial is designed so that participants will be assigned to receive the Synbiotic preparation or the placebo for the first four weeks, this will be followed by four weeks without treatment, and then they will switch to the opposite preparation for another four weeks.
- Conditions
- Aging
- Being tested
- Synbiotic (Synergy 1/B. longum), Placebo
- Keywords
- Older people, Synbiotic, Prebiotic, Probiotic, Bacteria, Immune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic (Synergy 1/B. longum)Dietary supplement
Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum
PlaceboDietary supplement
maltodextrose
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Experimental | Synbiotic (Synergy 1/B. longum) Receives: Dietary Supplement: Synbiotic (Synergy 1/B. longum) |
| Placebo | Placebo comparator | maltodextrose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in levels of faecal bifidobacteria
Measured: 4 weeks
Secondary outcomes (3)
Improvement in inflammatory markers linked to ageing
Measured: 4 weeks
Improvement in bowel habit and quality of life
Measured: 4 weeks
Reduction of genotoxic potential
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Investigators
- George Macfarlane, PhD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226212
- Sponsor's protocol ID
- 2010GA03
- Other IDs
- Funder
- Status last verified
- Apr 2013
- First submitted
- 18 Oct 2010
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steed H, Macfarlane GT, Blackett KL, Bahrami B, Reynolds N, Walsh SV, Cummings JH, Macfarlane S. Clinical trial: the microbiological and immunological effects of synbiotic consumption - a randomized double-blind placebo-controlled study in active Crohn's disease. Aliment Pharmacol Ther. 2010 Oct;32(7):872-83. doi: 10.1111/j.1365-2036.2010.04417.x.
PubMed 20735782Macfarlane 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 18215222Macfarlane S, Macfarlane GT, Cummings JH. Review article: prebiotics in the gastrointestinal tract. Aliment Pharmacol Ther. 2006 Sep 1;24(5):701-14. doi: 10.1111/j.1365-2036.2006.03042.x.
PubMed 16918875Furrie 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 15647189Woodmansey EJ, McMurdo ME, Macfarlane GT, Macfarlane S. Comparison of compositions and metabolic activities of fecal microbiotas in young adults and in antibiotic-treated and non-antibiotic-treated elderly subjects. Appl Environ Microbiol. 2004 Oct;70(10):6113-22. doi: 10.1128/AEM.70.10.6113-6122.2004.
PubMed 15466557Bartosch S, Fite A, Macfarlane GT, McMurdo ME. Characterization of bacterial communities in feces from healthy elderly volunteers and hospitalized elderly patients by using real-time PCR and effects of antibiotic treatment on the fecal microbiota. Appl Environ Microbiol. 2004 Jun;70(6):3575-81. doi: 10.1128/AEM.70.6.3575-3581.2004.
PubMed 15184159Macfarlane S, Cleary S, Bahrami B, Reynolds N, Macfarlane GT. Synbiotic consumption changes the metabolism and composition of the gut microbiota in older people and modifies inflammatory processes: a randomised, double-blind, placebo-controlled crossover study. Aliment Pharmacol Ther. 2013 Oct;38(7):804-16. doi: 10.1111/apt.12453. Epub 2013 Aug 20.
PubMed 23957631
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Synbiotic Use Improve Dysbiosis in the Gut Microbiome and Modify Inflammatory Processes in Older People
- ClinicalTrials.gov ID
- NCT01226212
- Acronym / sponsor ID
- 2010GA03
- Conditions
- Aging
- Keywords
- Older people, Synbiotic, Prebiotic, Probiotic, Bacteria, Immune
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Oct 2010 (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.
The objectives of this study are to use a nutritional change in the diet to improve gut health in older people. Ageing can result in major changes in the composition and activities of the bacteria in your gut, leading to a higher incidence of gastrointestinal infections, decreased intestinal motility and impaired bowel function as people get older. This can result in constipation or diarrhoea, increased levels of inflammation and reduced immune response to infection. Therefore, individuals aged 65 or over could benefit from safe and effective interventions that maintain a healthy balance of gut bacteria as well as restoring the immune response. Bacteria in the gut are known to promote health. Eating foods containing beneficial bacteria for example (probiotics) or food which contain substrates for the bacteria to grow on (prebiotics) can improve the balance of gut bacteria. The investigators will use a synbiotic with known anti-inflammatory properties, comprising a probiotic Bifidobacterium longum strain and inulin (Synergy 1), The synbiotic has been previously shown to be beneficial in reducing inflammation and to increase levels of beneficial bacteria in the gut in two studies in patients with inflammatory bowel disease. The investigators would now for these reasons, like to determine the effects of our Synbiotic on the gut bacteria and immune function of older individuals in a double-blinded, crossover, placebo controlled, randomised investigation involving 40 volunteers for three months. The trial is designed so that participants will be assigned to receive the Synbiotic preparation or the placebo for the first four weeks, this will be followed by four weeks without treatment, and then they will switch to the opposite preparation for another four weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Experimental | Dietary Supplement: Synbiotic (Synergy 1/B. longum)Synbiotic (Synergy 1/B. longum) |
| Placebo | Placebo comparator | Dietary Supplement: Placebomaltodextrose |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65-90 years
- BMI 18.5-30.0 kg m2.
Key exclusion criteria (7 listed)
- asplenia and other acquired or congenital immunodeficiencies
- any autoimmune disease
- connective tissue diseases
- self-reported symptoms of acute or recent infection (including use of antibiotics within the previous 3 months)
- taking probiotics or prebiotics, including lactulose for constipation
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 (Synergy 1/B. longum)Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum | Dietary supplement | Synbiotic |
| Placebomaltodextrose | Dietary supplement | Placebo |
Primary outcome
Increase in levels of faecal bifidobacteria
Time frame: 4 weeks
3 secondary outcomes
Improvement in inflammatory markers linked to ageing
Time frame: 4 weeks
Improvement in bowel habit and quality of life
Time frame: 4 weeks
Reduction of genotoxic potential
Time frame: 4 weeks
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 3 May 2013.
- Background: PubMed 20735782Steed H, Macfarlane GT, Blackett KL, Bahrami B, Reynolds N, Walsh SV, Cummings JH, Macfarlane S. Clinical trial: the microbiological and immunological effects of synbiotic consumption - a randomized double-blind placebo-controlled study in active Crohn's disease. Aliment Pharmacol Ther. 2010 Oct;32(7):872-83. doi: 10.1111/j.1365-2036.2010.04417.x.
- 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.
- Background: PubMed 16918875Macfarlane S, Macfarlane GT, Cummings JH. Review article: prebiotics in the gastrointestinal tract. Aliment Pharmacol Ther. 2006 Sep 1;24(5):701-14. doi: 10.1111/j.1365-2036.2006.03042.x.
- 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 15466557Woodmansey EJ, McMurdo ME, Macfarlane GT, Macfarlane S. Comparison of compositions and metabolic activities of fecal microbiotas in young adults and in antibiotic-treated and non-antibiotic-treated elderly subjects. Appl Environ Microbiol. 2004 Oct;70(10):6113-22. doi: 10.1128/AEM.70.10.6113-6122.2004.
- Background: PubMed 15184159Bartosch S, Fite A, Macfarlane GT, McMurdo ME. Characterization of bacterial communities in feces from healthy elderly volunteers and hospitalized elderly patients by using real-time PCR and effects of antibiotic treatment on the fecal microbiota. Appl Environ Microbiol. 2004 Jun;70(6):3575-81. doi: 10.1128/AEM.70.6.3575-3581.2004.
- Derived from this study: PubMed 23957631Macfarlane S, Cleary S, Bahrami B, Reynolds N, Macfarlane GT. Synbiotic consumption changes the metabolism and composition of the gut microbiota in older people and modifies inflammatory processes: a randomised, double-blind, placebo-controlled crossover study. Aliment Pharmacol Ther. 2013 Oct;38(7):804-16. doi: 10.1111/apt.12453. Epub 2013 Aug 20.
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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
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 (Synergy 1/B. longum) in people with Aging, 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 2 inclusion and 7 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 3 May 2013. 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. Some participants in this study may receive a placebo. 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?
Increase in levels of faecal bifidobacteria (time frame: 4 weeks). 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 NCT01226212, which also lists 7 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 3 May 2013.