Lallemand Health Solutions (Montreal) announced the results of a new study, published in Beneficial Microbes,1 confirming the safety and tolerability of three probiotic strains in healthy infants. The study, which was conducted by a team from Madrid University (Spain) and funded by Lallemand, found that the three probiotic strains present in Lallemand’s ProbioKid formula—Lactobacillus helveticus Rosell-52, Bifidobacterium infantis Rosell-33, and Bifidobacterium bifidum Rosell-71—were safe and well-tolerated.
According to the company, the aim of this study was to build on the substantial existing research and further establish the safety and tolerability of the strains. It noted that the ProbioKid formula and the individual strains recently obtained GRAS status in the U.S., and were also approved by Health Canada for children from three months old. The new study follows the “track record of safe use,” and “reinforces the assurance we have in our product,” said Bérengère Feuz, marketing group manager, Lallemand, in a press release.
The randomized, double-blind, placebo-controlled intervention study was conducted over a period of 12 weeks, with eight weeks of treatment. Researchers recruited 221 healthy infants between the ages of three and 12 months, and the subjects were then split into four groups. Three of the groups were given one of Lallemand’s three ProbioKid probiotic strains (3x109 colony-forming units, or CFU) daily, while the fourth group received an equivalent dose of a placebo and served as the control. Key areas of safety evaluation included growth (weight, height, and head circumference), adverse or serious adverse events, concentration of D-lactic acid in urine samples, characteristics of stools, and use of medication.
Pediatricians recorded measurements for all criteria over the course of four visits: one at the start of the study, a second at the end of the two-week run-in period, a third following the eight-week treatment period, and the last at the end of the two-week follow-up period. By the end of the study period, the study authors found no adverse or serious adverse events, and weight, length, and head circumference growth was consistent across all four groups. Per the study, “the changes in anthropometric measures showed equivalence for each of the three treatment groups when compared to the placebo,” leading the authors to conclude that the probiotics do not have any effect on growth. Finally, the concentration of D-lactic acid measured in urine samples were below the quantification limit, and stool characteristics were equivalent across all groups.
Of the study results, Feuz said: “We are very impressed by the quality and impact of this very well-designed study as it involves a large population of healthy infants and assesses independently each of the individual strains.” She added that the results of the study will also be used to conduct a secondary analysis with the goal of providing additional information about each strain’s interactions with the microbiota and immune system.
- Manzano S et al. “Safety and tolerability of three probiotics strains in health infants. A multi-centre randomized, double-blind, placebo-controlled trial.” Beneficial Microbes. Published online May 30, 2017.