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Three Rosell strains have been tested together and proven to survive stomach acidity and to reach the gut alive. The strains are Lactobacillus acidophilus Rosell-52, Bifidobacterium infantis Rosell-33, and Bifidobacterium bifidum Rosell-71). These strains were also combined with FOS fibres.
In May 2009, the Institut Rosell led a randomised, double-blind, placebo-controlled study1 on the three strains and found that the combination of probiotics and prebiotics could reduce the incidence of infant infections by 25%. The synbiotic (see Probiotics Learning Lab for more glossary terms) combination was shown to reduce the incidence of ear-nose-throat (ENT), bronchopulmonary, or gastric disorders in children during the winter season. We've talked more about this trial in our clinical trials article.
In January 2017, a multi-centre randomised, double-blind, placebo-controlled study of 221 healthy infants was conducted by the University of Madrid, looking at the safety and tolerance of the three strains of bacteria (Bifidobacterium infantis Rosell-33, Lactobacillus acidophilus Rosell-52 and Bifidobacterium bifidum Rosell-71)2. The infants were divided into four groups and each group was given either one of the three strains of probiotic bacteria or a placebo for an eight week intervention period. (Dosage used in the probiotic group was 3 Billion CFUs). The study collected data on the growth of the infants (weight, height and head circumference), any adverse events (AEs) or serious adverse events (SAEs) they had experienced, and amounts of D-lactic acid in urine samples and stool characteristics. The results showed that changes in growth measurements were the same across all four groups, as were the incidence of adverse and serious adverse events. The study concluded that these three strains of bacteria were safe to use and well-tolerated in infancy.
A year earlier, a different clinical trial had shown that the frequency of respiratory infections and wheezing in children, with and without asthma, significantly decreased after 3 months of supplementing with the synbiotic combination3. Children would typically experience an infection at least once per month, but after 3 months of taking this probiotic it became a rare occurrence, and after 6 months, infection and wheezing rate was under control with no incidences of these symptoms recorded for any of the children. These results were maintained with supplementation 9 months into the trial. The table below reflects the results.
Frequency of wheezing and respiratory infections in children during synbiotic supplementation
There was also a progressive increase in the total IgA serum and a decrease in IgE serum which was maintained during supplementation with the synbiotic. IgE has been known to play a crucial role in mediating allergic reactions and asthma. Low levels of IgA during childhood has been associated with a higher risk of developing asthma and allergies. See the Probiotics Learning Lab to read more about the clinical trial.
Manzano, S. et al. (2017) Safety and tolerance of three probiotic strains in healthy infants: a multi-centre randomized, double-blind, placebo-controlled trial; Beneficial Microbes, 2017 online.
Cazzola, M. et al. (2010) Immunomodulatory impact of synbiotic in TH1 and TH2 models of infection; Therapeutic Advances in Respiratory Disease 0(0) pp. 1-13
Cazzola, M. et al. (2010) Efficacy of a synbiotic supplementation in the prevention of common diseases in children: a randomized, double-blind, placebo-controlled pilot study; Therapeutic Advances in Respiratory Disease 0(0) pp. 1-8