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Synbiotic Approach to Immunity and Metabolism in the Elderly Study (SAIMES)

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ClinicalTrials.gov Identifier: NCT03168503
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
DR ADELE COSTABILE, University of Roehampton

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: LGG+Promitor™ Dietary Supplement: Promitor™ Dietary Supplement: LGG-PB12+Promitor™ Dietary Supplement: Maltodextrin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double Blind (Participant, Investigator,Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: LGG+Promitor™
synbiotic

Experimental: 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™
Soluble Corn Fiber

Experimental: 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.
Dietary Supplement: LGG-PB12+Promitor™
synbiotic

Placebo Comparator: Maltodextrin
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
Control




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168503


Locations
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United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Roehampton
Investigators
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Study Director: Glenn R Gibson The University of Reading

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Responsible Party: DR ADELE COSTABILE, Health Sciences Research Centre, Life Science Department, University of Roehampton
ClinicalTrials.gov Identifier: NCT03168503     History of Changes
Other Study ID Numbers: UREC14/06
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No