Butyrate producers as potential next-generation probiotics: safety assessment of the administration of Butyricicoccus pullicaecorum to healthy volunteers

Study ID Alternative Stable ID Type
EGAS00001003276 Other

Study Description

Advances in gut microbiota research have triggered interest in developing colon butyrate producers as niche-specific next-generation probiotics, targeted at increasing colon butyrate production and countering disease-associated microbiota alterations. Crucial steps in the development of next-generation probiotics are the design of formulations with a reasonable shelf life as well as the safety demonstration of an intervention in healthy volunteers. One such potential next-generation butyrate-producing probiotic is Butyricicoccus pullicaecorum 25-3T, with demonstrated safety in in vitro as well as in animal models. Here, we examined the strain's safety, tolerability, and impact on microbiota composition and metabolic activity in healthy volunteers in a randomized, double blind, placebo-controlled, crossover study in 30 healthy volunteers. Study design consisted of two four-week intervention periods (108 CFU B. pullicaecorum [treatment] or maltodextrin [placebo] per day) with a three-week washout in between. We assessed adverse events, blood parameters (primary endpoints), and fecal ... (Show More)

Study Datasets 1 dataset.

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Dataset ID Description Technology Samples
16S rRNA gene sequencing with Illumina MiSeq (V4 hypervariable region)
Illumina MiSeq 188

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