Skip to main content
Clinical Trials/NCT03168503
NCT03168503
Completed
Not Applicable

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

University of Roehampton1 site in 1 country40 target enrollmentDecember 2013
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Roehampton
Enrollment
40
Locations
1
Primary Endpoint
The modulation of the gut microbiota by synbiotics and PromitorTM inflammatory/immune biomarkers
Status
Completed
Last Updated
8 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
January 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Roehampton
Responsible Party
Principal Investigator
Principal Investigator

DR ADELE COSTABILE

Health Sciences Research Centre, Life Science Department

University of Roehampton

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The modulation of immune function by synbiotics and PromitorTM(Changes from baseline to 21 days synbiotics and PromitorTM treatment)

Study Sites (1)

Loading locations...

Similar Trials