Safety ofBifidobacterium animalissubsp.lactis(B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

Merenstein, Daniel; Tan, Tina P.; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert; Shara, Nawar; Sanders, Mary Ellen; Solano‐Aguilar, Gloria

doi:10.1080/19490976.2015.1005484

Cited by 28 publications

(12 citation statements)

References 34 publications

(41 reference statements)

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“…The first stage of this process was to conduct a phase I study in antibiotic-treated adults. (12) Our current study was conducted to establish the safety profile of a BB-12 ® -supplemented yogurt drink in healthy children aged 1–5 years. The long-term objective is to continue with the FDA/CBER IND staging process toward an efficacy study to determine the effects of BB-12 ® -supplemented yogurt on gastrointestinal disease states.…”

Section: Introductionmentioning

confidence: 99%

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB‐12‐Supplemented Yogurt in Healthy Children

Tan

Sanders³

et al. 2017

J. pediatr. gastroenterol. nutr.

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Objectives Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration (FDA) has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12® (BB-12®)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12®-supplemented yogurt on the gut microbiota of the children. Methods Sixty children aged 1–5 years were randomly assigned to consume four ounces of either BB-12®-supplemented yogurt or non-supplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events. Results A total of 186 non-serious adverse events were reported, with no significant differences between the control and BB-12® groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort. Conclusions BB-12®-supplemented yogurt is safe and well-tolerated when consumed by healthy children. This study will form the basis for future randomized clinical trials investigating the potential effects of BB-12®-supplemented yogurt in different disease states.

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Section: Introductionmentioning

confidence: 99%

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB‐12‐Supplemented Yogurt in Healthy Children

Tan

Sanders³

et al. 2017

J. pediatr. gastroenterol. nutr.

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“…Systematic reviews investigating the safety of probiotics have concluded that their use in humans does not lead to an increase in the risk of adverse events 29,30 . Since these meta-analyses, several additional phase 1 safety studies have been conducted, also documenting safety of certain probiotics used in different population groups [31][32][33][34] . However, safety has not been assessed thoroughly in many studies 29,30 , and some vulnerable patients in specific condition have also been identified at higher risk for adverse events in case of probiotic consumption 29 .…”

mentioning

confidence: 99%

Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial

Alvarez¹,

Tap²,

Chambaud³

et al. 2020

Sci Rep

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Many clinical studies have evaluated the effect of probiotics, but only a few have assessed their dose effects on gut microbiota and host. We conducted a randomized, double-blind, controlled intervention clinical trial to assess the safety (primary endpoint) of and gut microbiota response (secondary endpoint) to the daily ingestion for 4 weeks of two doses (1 or 3 bottles/day) of a fermented milk product (Test) in 96 healthy adults. The Test product is a multi-strain fermented milk product, combining yogurt strains and probiotic candidate strains Lactobacillus paracasei subsp. paracasei CNCM I-1518 and CNCM I-3689 and Lactobacillus rhamnosus CNCM I-3690. We assessed the safety of the Test product on the following parameters: adverse events, vital signs, hematological and metabolic profile, hepatic, kidney or thyroid function, inflammatory markers, bowel habits and digestive symptoms. We explored the longitudinal gut microbiota response to product consumption and dose, by 16S rRNA gene sequencing and functional contribution by shotgun metagenomics. Safety results did not show any significant difference between the Test and Control products whatever the parameters assessed, at the two doses ingested daily over a 4-week-period. Probiotic candidate strains were detected only during consumption period, and at a significantly higher level for the three strains in subjects who consumed 3 products bottles/day. The global structure of the gut microbiota as assessed by alpha and beta-diversity, was not altered by consumption of the product for four weeks. A zero-inflated beta regression model with random effects (ZIBR) identified a few bacterial genera with differential responses to test product consumption dose compared to control. Shotgun metagenomics analysis revealed a functional contribution to the gut microbiome of probiotic candidates.

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“…This includes gastric acid (Corcoran et al 2005), bile secretion (Begley et al 2005) and competition with the resident bacteria of the gut microbiota (Fooks and Gibson 2002). As safety requirement, the origin of the strains, their nonpathogenicity and the absence of transferable antibiotic resistance genes should also be assessed (Saarela et al 2000;Merenstein et al 2015).…”

mentioning

confidence: 99%

Probiotic and functional characterization of bifidobacteria of Indian human origin

et al. 2016

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Safety ofBifidobacterium animalissubsp.lactis(B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

Cited by 28 publications

References 34 publications

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB‐12‐Supplemented Yogurt in Healthy Children

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB‐12‐Supplemented Yogurt in Healthy Children

Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial

Probiotic and functional characterization of bifidobacteria of Indian human origin

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