The Effect of a Prebiotic, Probiotic and Synbiotic on the Gut Microbiota and Immune Response of Older Volunteers (GOS)

This study has been completed.
Sponsor:
Collaborator:
Danisco
Information provided by (Responsible Party):
Caroline Childs, University of Reading
ClinicalTrials.gov Identifier:
NCT01586247
First received: April 19, 2012
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

Healthy older volunteers will be recruited to a study where they will be given four different treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be collected and analysed for changes in faecal microbial populations and selected immune responses.


Condition Intervention
Gut Microbiota
Immune Function
Dietary Supplement: Synbiotic
Dietary Supplement: Placebo
Dietary Supplement: Prebiotic
Dietary Supplement: Probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-blind, Placebo-controlled, Randomized Crossover Study of a Prebiotic (Galacto-oligosaccharides, GOS), Probiotic (B.Lactis, BI07) and Synbiotic (GOS + BI07) on the Gut Microbiota and Immune Response of Older Volunteers

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • Changes to the gut microbiota [ Time Frame: Baseline and after 21d treatment ] [ Designated as safety issue: No ]
    The primary objective of this study is to determine the effect of GOS (administered at 8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic (8g/day of GOS and 109 CFU/day of B. lactis BI07) on the human gut microbiota. Changes in the gut microbiota will be determined by measuring bacterial population levels in human faeces using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridisation. Faecal pH will be measured and the production of short chain fatty acids (SCFA) will be analysed and quantified using high performance liquid chromatography (HPLC).


Secondary Outcome Measures:
  • Immune function [ Time Frame: Baseline and after 21d treatment ] [ Designated as safety issue: No ]
    To examine the effect of GOS (administered at 8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic (8g/day of GOS and 109 CFU/day of B. lactis BI07 ) on cellular immune function in 40 healthy older (≥60 years of age) volunteers. This will be achieved by investigating phagocytosis activity, natural killer cells which are CD4+, CD8+, CD25+ and CD2+ and CD3+ subsets, the marker of T-cell maturation period., salivary IgA levels, inflammatory markers (plasma - tumour necrosis factor (TNF), IL6, IL1, chemokines and soluble adhesion molecules).


Enrollment: 40
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synbiotic
8g/day gluco-oligosaccharide + 109 CFU/day B. lactis BI07
Dietary Supplement: Synbiotic
8g/day galacto-oligosaccharide + 10^9 CFU/day B.lactis
Other Name: GOS Bi-07
Experimental: Placebo
8g/day maltodextrin
Dietary Supplement: Placebo
8g/day maltodextrin
Experimental: Prebiotic
8g/day galacto-oligosaccharides (GOS)
Dietary Supplement: Prebiotic
8g/day galacto-oligosaccharide
Other Name: GOS
Experimental: Probiotic
109 CFU/day B. lactis BI07
Dietary Supplement: Probiotic
10^9 CFU/day B.lactis
Other Name: Bi-07

Detailed Description:

The primary objective of this study is to determine the effect of GOS (administered at 8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic (8g/day of GOS and 109 CFU/day of B. lactis BI07) on the human gut microbiota.

A double-blind, placebo-controlled, randomized crossover study will be conducted in 40 healthy older (≥60 years of age) volunteers. The placebo will consist of maltodextrin (a food grade ingredient, administered at 8g/day).

Changes in the gut microbiota will be determined by measuring bacterial population levels in human faeces using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridisation. Faecal pH will be measured and the production of short chain fatty acids (SCFA) will be analysed and quantified using high performance liquid chromatography (HPLC).

The secondary objective of this study is to examine the effect on cellular immune function. This will be achieved by investigating phagocytosis activity, natural killer cells which are CD4+, CD8+, CD25+ and CD2+ and CD3+ subsets, the marker of T-cell maturation period., salivary IgA levels, inflammatory markers (plasma - tumour necrosis factor (TNF), IL6, IL1, chemokines and soluble adhesion molecules).

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a signed consent form,
  • age >60 years
  • good general health
  • not in the residential care.

Exclusion Criteria:

  • evidence of physical or mental disease
  • planned major surgery
  • use of antibiotics within the previous six months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586247

Locations
United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Danisco
Investigators
Principal Investigator: Robert A Rastall University of Reading
  More Information

No publications provided

Responsible Party: Caroline Childs, Post doctoral research fellow, University of Reading
ClinicalTrials.gov Identifier: NCT01586247     History of Changes
Other Study ID Numbers: 07/47
Study First Received: April 19, 2012
Last Updated: April 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on April 16, 2014