Gut Microbiota Clinical Trial
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
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.
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).
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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