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

University of Reading

Status: Completed

Conditions: Gut Microbiota; Immune Function

Treatments: Dietary Supplement: Synbiotic; Dietary Supplement: Probiotic; Dietary Supplement: Prebiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01586247

07/47

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 4 patient groups

Synbiotic

Experimental group

Description:

8g/day gluco-oligosaccharide + 109 CFU/day B. lactis BI07

Treatment:

Dietary Supplement: Synbiotic

Placebo

Experimental group

Description:

8g/day maltodextrin

Treatment:

Dietary Supplement: Placebo

Prebiotic

Experimental group

Description:

8g/day galacto-oligosaccharides (GOS)

Treatment:

Dietary Supplement: Prebiotic

Probiotic

Experimental group

Description:

109 CFU/day B. lactis BI07

Treatment:

Dietary Supplement: Probiotic