Synbiotic Approach to Immunity and Metabolism in the Elderly Study

NCT03168503 | Completed

• 1 other identifier: UREC14/06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The modulation of immune function by synbiotics and PromitorTM

  Changes from baseline to 21 days synbiotics and PromitorTM treatment

Other Outcomes (2)

• Digestive symptoms

  Changes from baseline to 21 days synbiotics and PromitorTM treatment

• Microbiota activity (intestinal gas production)

  Changes from baseline to 21 days synbiotics and PromitorTM treatment

Study Arms (4)

LGG+Promitor™

EXPERIMENTAL

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™

EXPERIMENTAL

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+Promitor™

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

LGG+Promitor™ DIETARY_SUPPLEMENT

synbiotic

LGG+Promitor™

Promitor™ DIETARY_SUPPLEMENT

Soluble Corn Fiber

Promitor™

LGG-PB12+Promitor™ DIETARY_SUPPLEMENT

synbiotic

LGG-PB12+Promitor™

Maltodextrin DIETARY_SUPPLEMENT

Control

Maltodextrin

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, RG6 6AP, United Kingdom

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

• Glenn R Gibson

  The University of Reading

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind (Participant, Investigator,Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Research Centre, Life Science Department

Model Details: Crossover assignment

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 30, 2017
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)