Skip to main content
OpenTrials
Completed

NCT Number: NCT01586247

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gut Microbiota Immune Function

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Synbiotic

Dietary Supplement

8g/day galacto-oligosaccharide + 10^9 CFU/day B.lactis

Other names: GOS Bi-07

Placebo

Dietary Supplement

8g/day maltodextrin

Prebiotic

Dietary Supplement

8g/day galacto-oligosaccharide

Other names: GOS

Probiotic

Dietary Supplement

10^9 CFU/day B.lactis

Other names: Bi-07

Primary outcomes

  1. Changes to the gut microbiota

    Time frame: Baseline and after 21d treatment

    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 outcomes

  1. Immune function

    Time frame: Baseline and after 21d treatment

    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).

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Danisco

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 26, 2012
Registry last updated
Apr 27, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.