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

Abstract

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.

The Fatty-Acid Hydratase Activity of the Most Common Probiotic Microorganisms

“…To complete our strain selection, we investigated the hydratase activity of two further bacteria, namely Bacillus coagulans (Colinox ® ) and Streptococcus salivarius (ATCC BAA 1024) as well as that of Saccharomyces boulardii (SB80 ® , CNCM I-3799), which is the only yeast widely used as a probiotic. All these microorganisms are commercially available because they are currently used to restore the gut and oral cavity flora and thus improve human health [43][44][45][46][47][48][49][50][51][52][53][54][55].…”

Microbiome Composition in Pediatric Populations from Birth to Adolescence: Impact of Diet and Prebiotic and Probiotic Interventions

“…Two general probiotic approaches have been taken to influence the infant or child microbiota. The first approach is to administer the probiotic to the mother during pregnancy Fecal pH: SCF 20 g < control, SCF 10 g ↔ SCFA concentrations [56] and then to either the mother and/or infant postpartum [63][64][65][66][67][68][69][70] (Table 3), and the second is to administer the probiotic directly to the infant or child [71][72][73][74][75][76][77][78][79][80][81][82][83][84] (Table 4). For the first approach, most studies gave probiotics to the mothers of infants with high-risk of allergy, with the goal of prevention of allergic disease, such as eczema, asthma and allergic rhinitis [63-65, 69, 70].…”

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

“…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 – 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 .…”