BioGaia´s probiotic can help prevent antibiotic-associated diarrhea in children
NewsSeptember 1, 2025
In a recent study, published in the European Journal of Pediatrics, BioGaia´s patented bacteria strain, Limosilactobacillus reuteri DSM 17938, was shown to prevent antibiotic-associated diarrhea (AAD) in children.
The prospective, multi-center, randomized, placebo-controlled clinical trial, known as the PEARL Study, investigated the effect of L. reuteri DSM 17938 in children aged between 6 months and 10 years, receiving amoxicillin and clavulanic acid to treat acute otitis media or acute rhinosinusitis.
Results showed a statistically significant reduction in the incidence of AAD in the probiotic group compared to placebo, at 14-, 21- and 56-days follow-up.
Subanalyses showed that the effect was the strongest in children with acute otitis media and after 21 days of probiotics use. The data presented in this large study, involving 720 participants, support the role of BioGaia’s probiotic as an effective and safe adjunct to antibiotic therapy in pediatric care.
“These results add to the growing body of evidence supporting L. reuteri DSM 17938 in maintaining gut homeostasis and protecting the gut microbiome during antibiotic treatment. This is especially important for children, where preventing diarrhea can have a big impact on overall recovery and well-being”, says Gianfranco Grompone, Chief Scientific Officer at BioGaia.
Antibiotic-associated diarrhea is a common side effect of antibiotic treatment, caused by disruption of the gut microbiota. Probiotics like L. reuteri DSM 17938 help restore balance to the microbiome, which can reduce the risk of gastrointestinal disturbances.
The PEARL study strengthens BioGaia’s position as a leader in evidence-based probiotics and supports its mission to promote health through the microbiome.
Link to study: https://link.springer.com/article/10.1007/s00431-025-06249-8
Full reference:
Dinleyici EC, Ozen M, Guven S, Dalgic N, Karbuz A, Sutcu M, et al. Effect of Limosilactobacillus reuteri DSM17938 to prevent antibiotic-associated diarrhea in children: prospective, multi-center, randomized, placebo-controlled clinical trial (PEARL Study). Eur J Pediatr. 2025;184(7):408. doi:10.1007/s00431-025-06249-8
Glossary:
Prospective study
A study that follows participants forward in time to observe how a treatment affects them.
Multicenter study
A study conducted at several hospitals or research centers simultaneously to obtain more reliable results.
Randomized, placebo-controlled clinical trial
A scientific study in which participants are randomly assigned to groups: one receives the treatment being tested (the probiotic), and the other receives a placebo (inactive treatment). This is considered the "gold standard" for proving that a treatment is truly effective.
Acute otitis media
The medical term for acute middle ear infection.
Acute rhinosinusitis
Inflammation of the nasal passages and sinuses, often referred to as sinus infection.
Subanalyses
Additional analyses of data to determine whether the results are particularly strong in certain subgroups, such as children with ear infections.
Homeostasis
The body’s ability to maintain a stable balance in its functions, for example, keeping the gut microbiota in balance.
Microbiota
All bacteria, viruses, and other microorganisms that live in and on the human body, for example in the gut.
Microbiome
All bacteria, viruses, and other microorganisms that live in and on the human body, for example in the gut. The ecosystem created by all these bacteria, viruses, and other microorganisms living in and on the body, such as in the gut.
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Mikaela Idermark Stern, Corporate Communications
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About BioGaia
BioGaia is a Swedish probiotics company that has been at the forefront of microbiome research for more than 35 years. BioGaia develops, markets, and sells probiotic products focused on gut health, immune health, and oral health. The products are sold through local distribution partners or via own distribution in over 100 markets. The class B share of the Parent Company BioGaia AB is quoted on the Mid Cap segment of Nasdaq Stockholm. biogaiagroup.com