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

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

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.

Study Overview

• Status: Completed
• Conditions: Gut Microbiota; Immune Function
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Synbiotic; Dietary supplement: Prebiotic; Dietary supplement: Probiotic

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: GOS
Experimental: Probiotic; 109 CFU/day B. lactis BI07	Dietary supplement: Probiotic; 10^9 CFU/day B.lactis; Other Names: Bi-07

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes to the gut microbiota	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).	Baseline and after 21d treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune function	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).	Baseline and after 21d treatment

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: Danisco
• Investigators: Principal Investigator: Robert A Rastall, University of Reading

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Estimate): April 27, 2012
• Last Update Submitted That Met QC Criteria: April 26, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 07/47