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Completed

NCT Number: NCT03168503

Synbiotic Approach to Immunity and Metabolism in the Elderly Study

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.

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Key information

Conditions

Healthy

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading

Reading, RG6 6AP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

LGG+Promitor™

Dietary Supplement

synbiotic

Promitor™

Dietary Supplement

Soluble Corn Fiber

LGG-PB12+Promitor™

Dietary Supplement

synbiotic

Maltodextrin

Dietary Supplement

Control

Primary outcomes

  1. 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

  1. The modulation of immune function by synbiotics and PromitorTM

    Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment

    Blood samples analysis to assess changes in cytokines production

Other outcomes

  1. Digestive symptoms

    Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment

    Bristol diary form

  2. Microbiota activity (intestinal gas production)

    Time frame: Changes from baseline to 21 days synbiotics and PromitorTM treatment

    Intestinal gas evacuation on standardized diet

Sponsors and collaborators

Lead sponsor

University of Roehampton

Other

Registry information

Official study 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

Acronym: SAIMES

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 30, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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