Butyrate producers as potential next-generation probiotics : safety assessment of the administration of Butyricicoccus pullicaecorum to healthy volunteers
| Autor: | Gwen Falony, Mireia Valles-Colomer, Jun Wang, Leen Boesmans, Kristin Verbeke, Venessa Eeckhaut, Filip Van Immerseel, Richard Ducatelle, Jeroen Raes |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Agriculture and Food Sciences Physiology lcsh:QR1-502 microbiome Gut flora Pharmacology Biochemistry METABOLITES lcsh:Microbiology DISEASE law.invention Probiotic 0302 clinical medicine law SCOPE Medicine and Health Sciences Medicine tolerance biology next-generation probiotic MICROBIOTA QR1-502 Computer Science Applications Tolerability Modeling and Simulation BACTERIA TESTS 030211 gastroenterology & hepatology metabolome probiotic safety CONSENSUS STATEMENT next-generation Butyrate PREBIOTICS Microbiology 03 medical and health sciences Genetics Microbiome Molecular Biology INTERNATIONAL SCIENTIFIC ASSOCIATION Ecology Evolution Behavior and Systematics business.industry Biology and Life Sciences biology.organism_classification Crossover study Butyricicoccus pullicaecorum 030104 developmental biology Blood chemistry Calprotectin business |
| Zdroj: | MSYSTEMS mSystems, Vol 3, Iss 6 (2018) mSystems, Vol 3, Iss 6, p e00094-18 (2018) |
| ISSN: | 2379-5077 |
| Popis: | 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 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. The study design consisted of two 4-week intervention periods (108 CFU B. pullicaecorum [treatment] or maltodextrin [placebo] per day) with a 3-week washout in between. We assessed adverse events, blood parameters (primary endpoints), and fecal microbiota composition and metabolite profiles (secondary endpoints). The number of reported adverse events during the B. pullicaecorum treatment was similar to that of placebo intervention, as were observed changes in blood chemistry parameters, bowel habits, and fecal calprotectin concentrations. Administration of the strain did not induce any disruptive effect in microbiota composition or metabolic activity. In this first human intervention trial with a butyrate-producing Clostridium cluster IV isolate, we demonstrated B. pullicaecorum 25-3T administration to be both safe and well tolerated by healthy participants. This safety study paves the way for the further development of the strain as a next-generation probiotic. IMPORTANCE This study is the first to determine the safety and tolerance in humans of a butyrate-producing Clostridium cluster IV next-generation probiotic. Advances in gut microbiota research have triggered interest in developing colon butyrate producers as next-generation probiotics. Butyricicoccus pullicaecorum 25-3T is one such potential probiotic, with demonstrated safety in vitro as well as in animal models. Here, we produced an encapsulated B. pullicaecorum formulation that largely preserved its viability over an 8-month storage period at 4°C. Administration of this formulation to healthy volunteers allowed us to establish the intervention as safe and well tolerated. The probiotic intervention did not cause disruptive alterations in the composition or metabolic activity of health-associated microbiota. The results presented pave the way for the exploration of the impact of the strain on microbiota alterations in a clinical setting. ispartof: MSYSTEMS vol:3 issue:6 ispartof: location:United States status: accepted |
| Databáze: | OpenAIRE |
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