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

(2018) MSYSTEMS. 3(6).
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Abstract
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 25-3(T), 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 (10(8) 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 butyrateproducing Clostridium cluster IV isolate, we demonstrated B. pullicaecorum 25-3(T) 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 25-3(T) 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 degrees 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.
Keywords
INTERNATIONAL SCIENTIFIC ASSOCIATION, CONSENSUS STATEMENT, MICROBIOTA, DISEASE, METABOLITES, PREBIOTICS, BACTERIA, TESTS, SCOPE, Butyricicoccus pullicaecorum, metabolome, microbiome, next-generation, probiotic, safety, tolerance

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MLA
Boesmans, Leen et al. “Butyrate Producers as Potential Next-generation Probiotics : Safety Assessment of the Administration of Butyricicoccus Pullicaecorum to Healthy Volunteers.” MSYSTEMS 3.6 (2018): n. pag. Print.
APA
Boesmans, L., Valles-Colomer, M., Wang, J., Eeckhaut, V., Falony, G., Ducatelle, R., Van Immerseel, F., et al. (2018). Butyrate producers as potential next-generation probiotics : safety assessment of the administration of Butyricicoccus pullicaecorum to healthy volunteers. MSYSTEMS, 3(6).
Chicago author-date
Boesmans, Leen, Mireia Valles-Colomer, Jun Wang, Venessa Eeckhaut, Gwen Falony, Richard Ducatelle, Filip Van Immerseel, Jeroen Raes, and Kristin Verbekem. 2018. “Butyrate Producers as Potential Next-generation Probiotics : Safety Assessment of the Administration of Butyricicoccus Pullicaecorum to Healthy Volunteers.” Msystems 3 (6).
Chicago author-date (all authors)
Boesmans, Leen, Mireia Valles-Colomer, Jun Wang, Venessa Eeckhaut, Gwen Falony, Richard Ducatelle, Filip Van Immerseel, Jeroen Raes, and Kristin Verbekem. 2018. “Butyrate Producers as Potential Next-generation Probiotics : Safety Assessment of the Administration of Butyricicoccus Pullicaecorum to Healthy Volunteers.” Msystems 3 (6).
Vancouver
1.
Boesmans L, Valles-Colomer M, Wang J, Eeckhaut V, Falony G, Ducatelle R, et al. Butyrate producers as potential next-generation probiotics : safety assessment of the administration of Butyricicoccus pullicaecorum to healthy volunteers. MSYSTEMS. 2018;3(6).
IEEE
[1]
L. Boesmans et al., “Butyrate producers as potential next-generation probiotics : safety assessment of the administration of Butyricicoccus pullicaecorum to healthy volunteers,” MSYSTEMS, vol. 3, no. 6, 2018.
@article{8599480,
  abstract     = {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 25-3(T), 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 (10(8) 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 butyrateproducing Clostridium cluster IV isolate, we demonstrated B. pullicaecorum 25-3(T) 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 25-3(T) 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 degrees 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.},
  articleno    = {e00094-18},
  author       = {Boesmans, Leen and Valles-Colomer, Mireia and Wang, Jun and Eeckhaut, Venessa and Falony, Gwen and Ducatelle, Richard and Van Immerseel, Filip and Raes, Jeroen and Verbekem, Kristin},
  issn         = {2379-5077},
  journal      = {MSYSTEMS},
  keywords     = {INTERNATIONAL SCIENTIFIC ASSOCIATION,CONSENSUS STATEMENT,MICROBIOTA,DISEASE,METABOLITES,PREBIOTICS,BACTERIA,TESTS,SCOPE,Butyricicoccus pullicaecorum,metabolome,microbiome,next-generation,probiotic,safety,tolerance},
  language     = {eng},
  number       = {6},
  pages        = {11},
  title        = {Butyrate producers as potential next-generation probiotics : safety assessment of the administration of Butyricicoccus pullicaecorum to healthy volunteers},
  url          = {http://dx.doi.org/10.1128/mSystems.00094-18},
  volume       = {3},
  year         = {2018},
}

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