An interventional study of LGG+Promitor™ and Promitor™ in Healthy, sponsored by University of Roehampton. Completed at 1 site in United Kingdom. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by University of Roehampton · Not applicable, Interventional, and Prevention
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.
University of Roehampton is the lead sponsor of 23 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Dietary Supplement: LGG+Promitor™
Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast.
Dietary Supplement: 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.
Dietary Supplement: LGG-PB12+Promitor™
Maltodextrin (an oligosaccharide without prebiotic effect) 12g delivered and served as dry powders to be consumed as 250 ml beverages at breakfast.
Dietary Supplement: Maltodextrin
synbiotic
Soluble Corn Fiber
synbiotic
Control
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
Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment
The modulation of immune function by synbiotics and PromitorTM
Blood samples analysis to assess changes in cytokines production
Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment
Digestive symptoms
Bristol diary form
Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment
Microbiota activity (intestinal gas production)
Intestinal gas evacuation on standardized diet
Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment
Plan to share: No
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Roehampton