Efficacy of a tracer device to measure colon chemistry
Research type
Research Study
Full title
A pilot study to evaluate the efficacy of a tracer device to measure changes in colonic luminal environment induced by the consumption of Bifidobacterium animalis ssp. lactis BB-12® and fructooligosaccharides
IRAS ID
127139
Contact name
Robin C Spiller
Contact email
Research summary
Probiotics are live microorganisms that have beneficial health effects when consumed in sufficient amounts, while prebiotics are carbohydrates that are not digestible by humans but are substrates for probiotic and some colonic bacteria. There are currently significant efforts committed to the generation of clinical evidence to explain the impact of probiotics in human health, but there is still no technology capable of measuring gut response to probiotic interventions. Probiotic bacteria in the colon produce short-chain fatty acids (SCFA) and other substances (microbial activity markers) by fermenting food that escapes digestion in the small intestine. However, large part of SCFA is absorbed along the colon, so SCFA in stools do not reflect the colonic profile. The assay to be tested in this study consists of a tracer device made of silicone enclosed in a delayed-release capsule designed to open in the colon. The tracer device is swallowed and the silicone tracer is later recovered from the stools and analysed. Laboratory tests simulating physiological conditions showed that the tracer can bind and retain microbial activity markers.
Healthy individuals of at least 18y of age will follow a two-week run-in period with restricted consumption of fermented products, then assigned to a six-day placebo (13g maltodextrin) followed by a six-day symbiotic (13.5g fructooligosaccharides + Bifidobacterium animalis ssp. lactis BB-12®). Study days will be carried out in 6th day of placebo and symbiotic periods, in the Medical Physics Research Unit, Queen`s Medical Centre, when volunteers will be asked to swallow the tracer device and a Bravo pH capsule. For a period of 8h after administration, gamma camera images will be taken every 20 min and pH will be monitored continuously with an external receiver. Volunteers will be asked to collect stools and the devices will be collected and analysed for microbial activity markers.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
13/EM/0336
Date of REC Opinion
24 Sep 2013
REC opinion
Favourable Opinion