Gut Microbiota Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized Crossover Study to Determine the Effects of Xylooligosaccharides (XOS), B. Lactis (BI07) and XOS + BI07 Upon the Gut Microbiota and Immune Response of Healthy Volunteers
Healthy 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 XOS (administered at
8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic combination of both
(8g/day XOS and 109 CFU/day B. lactis BI07) on the human gut microbiota.
A double-blind, placebo-controlled, randomized crossover study will be conducted in 44
healthy volunteers. The placebo will be 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 fluorescence in situ hybridisation (FISH) with 16S rRNA targeted
oligonucleotide probes. Concentrations of short chain fatty acids (SCFA) will be quantified
using gas chromatography (GC).
In addition to analyses performed on the samples at the University of Reading, analyses on
microbial metabolites and selected members of the microbiota will also be performed at
Danisco Finland, Kantvik. University of Reading will therefore provide Danisco Kantvik with
faecal samples of appropriate size.
The secondary objective of this study is to examine the effects of XOS (8g/day), B. lactis
BI07 (109 CFU/day) and the synbiotic (8g/day of XOS and 109 CFU/day of B. lactis BI07) on
bowel function, immune function and plasma lipids in 44 healthy volunteers. This will be
achieved using volunteer diaries of bowel function and mood, and by investigating total
plasma lipids, mucosal immunity (salivary and faecal IgA), total leukocyte numbers,
expression of cell surface markers on immune cells to identify cell subsets and activation
markers, production of inflammatory markers by whole blood cultures, plasma chemokines,
phagocytosis and oxidative burst by monocytes and granulocytes, plasma/serum
immunoglobulins, acute phase proteins, complement proteins 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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