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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LGG+Promitorâ„¢ | Experimental | LGG:10^12 CFU/g Lactobacillus rhamnosus GG (commercialised as LGG) combined with Promitorâ„¢:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. |
|
| Promitorâ„¢ | Experimental | Promitorâ„¢:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. |
|
| LGG-PB12+Promitorâ„¢ | Experimental | LGG-PB12:10^12 CFU/g of a pilus-less derivative L. rhamnosus GG combined with Promitorâ„¢:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGG+Promitorâ„¢ | Dietary Supplement | synbiotic |
| |
| Promitorâ„¢ |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Changes from baseline to 21 days synbiotics and PromitorTM treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The modulation of immune function by synbiotics and PromitorTM | Blood samples analysis to assess changes in cytokines production | Changes from baseline to 21 days synbiotics and PromitorTM treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive symptoms | Bristol diary form | Changes from baseline to 21 days synbiotics and PromitorTM treatment |
| Microbiota activity (intestinal gas production) | Intestinal gas evacuation on standardized diet |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn R Gibson | The University of Reading | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food and Nutritional Sciences, University of Reading | Reading | RG6 6AP | United Kingdom |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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Crossover assignment
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Double Blind (Participant, Investigator,Outcomes Assessor)
| Dietary Supplement |
Soluble Corn Fiber |
|
| LGG-PB12+Promitorâ„¢ | Dietary Supplement | synbiotic |
|
| Maltodextrin | Dietary Supplement | Control |
|
| Changes from baseline to 21 days synbiotics and PromitorTM treatment |