HealthySAIMESNCT03168503
Synbiotic Approach to Immunity and Metabolism in the Elderly Study
A study testing LGG+Promitor™, Promitor™ and LGG-PB12+Promitor™ in people with Healthy, run by University of Roehampton at 1 site in United Kingdom.
Trial summary
The aging process leads to a marked decline in immune function (immunosenescence), causing a significant reduction in immune response after vaccination or infections. Dietary intervention is an attractive, safe and non-invasive way to impact on gut bacteria and subsequently the functioning of the immune system. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LGG+Promitor™, Promitor™ and LGG-PB12+Promitor™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Jan 2015
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 60 and 80 years of age.
- in good general health, defined as no comorbidities requiring regular medical follow up
- Ability to communicate well with the investigator and to comply with the requirements of the entire study
Who cannot join
- History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks and during the trial period
- Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study
- Undergone surgical resection of any part of the bowel
- History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
- Currently prescribed immunosuppressive drugs
- Intention to use regularly other medication which affects gastrointestinal motility and/or perception
- Current or recent history (within 12 months) of significant drug or alcohol abuse or dependence
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, RG6 6AP
About this study
Official title: Randomised, Double-blind, Placebo Controlled Cross-over Study to Determine the Beneficial Effects of Synbiotics and PromitorTM (Soluble Corn Flour)on Metabolism and Immunity in Healthy 60-80 Years Old Individuals
The aging process leads to a marked decline in immune function (immunosenescence), causing a significant reduction in immune response after vaccination or infections. Dietary intervention is an attractive, safe and non-invasive way to impact on gut bacteria and subsequently the functioning of the immune system. The ability of the dietary supplementation to alter these functions can be of particular importance in those groups that have an underdeveloped, poorly functioning immune system such as infants, immuno-compromised subjects or elderly. Research over the past two decades has provided evidence that administration of probiotics (live microorganisms which, when administered in adequate amounts, confer a health benefit on the host) could enhance immune function. Lactobacilli and bifidobacteria are the most common probiotics used in humans and various strains have been shown to have immunostimulatory properties in vitro and in experimental models, these properties include modulation of cytokine production. evidence exists of the immunostimulating effects of certain probiotics and the potential to use prebiotics to increase the levels of beneficial bacteria (which are known to be reduced in elderly population). Furthermore, by providing a probiotic at the same time as a prebiotic conditions for survival are enhanced. To date, only a small number of studies conducted have been randomised and/or placebo controlled to unequivocally demonstrate efficacies.
Read the detailed description
The aim of this study is to investigate the effect of probiotic Lactobacillus rhamnosus GG (commercialised as LGG), a pilus-less derivative L. rhamnosus GG (LGG-PB12)combined with a putative prebiotic PromitorTM (soluble corn fiber) i.e. a synbiotics and PromitorTM (SCF alone) on the faecal microbiota composition, metabolism and immunity in healthy individuals aged 60-80 years.
It consists of a 3 week randomised intervention treatment periods with the synbiotics, prebiotic and placebo control. Any adverse medical events which occur during the trial (e.g. headache, gut symptoms) should be recorded in a diary along with medication taken.
- Conditions
- Healthy
- Being tested
- LGG+Promitor™, Promitor™, LGG-PB12+Promitor™, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGG+Promitor™Dietary supplement
synbiotic
Promitor™Dietary supplement
Soluble Corn Fiber
LGG-PB12+Promitor™Dietary supplement
synbiotic
MaltodextrinDietary supplement
Control
| Study group | Role | What they receive |
|---|---|---|
| LGG+Promitor™ | Experimental | LGG:10^12 CFU/g Lactobacillus rhamnosus GG (commercialised as LGG) combined with Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. Receives: Dietary Supplement: LGG+Promitor™ |
| Promitor™ | Experimental | Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. Receives: Dietary Supplement: Promitor™ |
| LGG-PB12+Promitor™ | Experimental | LGG-PB12:10^12 CFU/g of a pilus-less derivative L. rhamnosus GG combined with Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. Receives: Dietary Supplement: LGG-PB12+Promitor™ |
| Maltodextrin | Placebo comparator | Maltodextrin (an oligosaccharide without prebiotic effect) 12g delivered and served as dry powders to be consumed as 250 ml beverages at breakfast. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modulation of the gut microbiota by synbiotics and PromitorTM inflammatory/immune biomarkers
Fecal16S rRNA amplicon sequencing to assess changes in fecal bacterial abundance and species diversity
Measured: Changes from baseline to 21 days synbiotics and PromitorTM treatment
Secondary outcomes (1)
The modulation of immune function by synbiotics and PromitorTM
Blood samples analysis to assess changes in cytokines production
Measured: Changes from baseline to 21 days synbiotics and PromitorTM treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startDec 2013
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Crossover assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- Glenn R Gibson, Study director, The University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168503
- Sponsor's protocol ID
- UREC14/06
- Acronym
- SAIMES
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo Controlled Cross-over Study to Determine the Beneficial Effects of Synbiotics and PromitorTM (Soluble Corn Flour)on Metabolism and Immunity in Healthy 60-80 Years Old Individuals
- ClinicalTrials.gov ID
- NCT03168503
- Acronym / sponsor ID
- SAIMES / UREC14/06
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 May 2017 (actual)
- 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 aging process leads to a marked decline in immune function (immunosenescence), causing a significant reduction in immune response after vaccination or infections. Dietary intervention is an attractive, safe and non-invasive way to impact on gut bacteria and subsequently the functioning of the immune system. The ability of the dietary supplementation to alter these functions can be of particular importance in those groups that have an underdeveloped, poorly functioning immune system such as infants, immuno-compromised subjects or elderly. Research over the past two decades has provided evidence that administration of probiotics (live microorganisms which, when administered in adequate amounts, confer a health benefit on the host) could enhance immune function. Lactobacilli and bifidobacteria are the most common probiotics used in humans and various strains have been shown to have immunostimulatory properties in vitro and in experimental models, these properties include modulation of cytokine production. evidence exists of the immunostimulating effects of certain probiotics and the potential to use prebiotics to increase the levels of beneficial bacteria (which are known to be reduced in elderly population). Furthermore, by providing a probiotic at the same time as a prebiotic conditions for survival are enhanced. To date, only a small number of studies conducted have been randomised and/or placebo controlled to unequivocally demonstrate efficacies.
Detailed description
The aim of this study is to investigate the effect of probiotic Lactobacillus rhamnosus GG (commercialised as LGG), a pilus-less derivative L. rhamnosus GG (LGG-PB12)combined with a putative prebiotic PromitorTM (soluble corn fiber) i.e. a synbiotics and PromitorTM (SCF alone) on the faecal microbiota composition, metabolism and immunity in healthy individuals aged 60-80 years.
It consists of a 3 week randomised intervention treatment periods with the synbiotics, prebiotic and placebo control. Any adverse medical events which occur during the trial (e.g. headache, gut symptoms) should be recorded in a diary along with medication taken.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Crossover assignment
| Arm | Type | Receives |
|---|---|---|
| LGG+Promitor™ | Experimental | Dietary Supplement: LGG+Promitor™LGG:10^12 CFU/g Lactobacillus rhamnosus GG (commercialised as LGG) combined with Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. |
| Promitor™ | Experimental | Dietary Supplement: Promitor™Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. |
| LGG-PB12+Promitor™ | Experimental | Dietary Supplement: LGG-PB12+Promitor™LGG-PB12:10^12 CFU/g of a pilus-less derivative L. rhamnosus GG combined with Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin (an oligosaccharide without prebiotic effect) 12g delivered and served as dry powders to be consumed as 250 ml beverages at breakfast. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 60 and 80 years of age.
- in good general health, defined as no comorbidities requiring regular medical follow up
- Ability to communicate well with the investigator and to comply with the requirements of the entire study
Key exclusion criteria (8 listed)
- History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks and during the trial period
- Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study
- Undergone surgical resection of any part of the bowel
- History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
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 |
|---|---|---|
| LGG+Promitor™synbiotic | Dietary supplement | LGG+Promitor™ |
| Promitor™Soluble Corn Fiber | Dietary supplement | Promitor™ |
| LGG-PB12+Promitor™synbiotic | Dietary supplement | LGG-PB12+Promitor™ |
| MaltodextrinControl | Dietary supplement | Maltodextrin |
Primary outcome
The modulation of the gut microbiota by synbiotics and PromitorTM inflammatory/immune biomarkers
Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment
Fecal16S rRNA amplicon sequencing to assess changes in fecal bacterial abundance and species diversity
1 secondary outcome
The modulation of immune function by synbiotics and PromitorTM
Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment
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 30 May 2017.
- Individual participant dataSharing planned: No
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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.
Glenn R Gibson study director
The University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LGG+Promitor™, Promitor™ and LGG-PB12+Promitor™ in people with Healthy, run by University of Roehampton 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 3 inclusion and 8 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 30 May 2017. 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?
The modulation of the gut microbiota by synbiotics and PromitorTM inflammatory/immune biomarkers (time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.