Otibiome is a clinically evaluated probiotic designed to break the cycle of recurrent acute otitis media (AOM) in children. Derived from Ligilactobacillus salivarius PS7, the patented probiotic strain was originally isolated from human breast milk.
Scientific research shows that the probiotic has antimicrobial activity and can fight off pathogens that cause ear infections thus reducing the number of AOM episodes, promoting faster recovery, and reducing the need for antibiotic treatment.
However, Otibiome, which has already been commercialized as ‘Elebiotic’ by Spain-based pharmaceutical group Casen Recordati, is also compatible with antibiotic treatment when administered two hours apart.
“Otibiome is based on the probiotic strain L. salivarius PS7, originally isolated from human breast milk and selected for its antagonistic activity against otitis-related pathogens,” said Ana Nunes, business unit director for microbiome and probiotics at Zinereo Pharma, a company of Zendal.
“Otibiome has been commercialized in Spain as a microbiome-based strategy aimed at reducing recurrence of AOM in children with recurrent episodes. PS7 is one of the few strains specifically developed and clinically evaluated in this precise context.”
Probiotic strain shown to reduce number of otitis episodes by 84%
AOM is a painful bacterial infection affecting the middle ear, causing inflammation and fluid build-up. It is the most common bacterial infection in children, with eight in 10 experiencing at least one episode before the age of five.
This high incidence rate means that AOM is the leading cause of antibiotic prescriptions in children, both in high and low-income countries.
Given concerns around antimicrobial resistance, researchers have begun to explore whether probiotics can restore the middle ear and nasopharyngeal microbiota, thereby offering an alternative or adjunctive approach to antibiotics.
One prospective pilot clinical study of 61 children, published in Nutrients, found that oral intake of L. salivarius PS7 over six months led to an 84% reduction in the number of episodes of AOM in comparison to those observed in the same population during the six months preceding the probiotic intervention.
The authors from Probisearch (a company of Zendal) and Casen Recordati reported that this reduction was higher than what has been observed in previous studies which used other probiotic strains, such as Lactobacillus rhamnosus GG and LC705, and Bifidobacterium breve 99.
“Over a six-month supplementation period, the total number of AOM episodes decreased from 251 episodes in the six months prior to intervention to 40 episodes during supplementation,” said Nunes. “Additionally, 70% of children did not experience any AOM episode during the study period. The study also reported a reduction in antibiotic use during supplementation compared with the previous six months.”
The researchers suggest that the proposed mechanism of action involves PS7’s antimicrobial activity against several otitis-related pathogens, with microbiological analyses showing a reduction in nasopharyngeal carriage of ‘otopathogens’.
So far, research on PS7 and AOM has only been conducted in those aged 10 months to 6 years. Otibiome is therefore recommended for children, but adult applications could be considered in recurrent cases, said Nunes.
Scaling up
Otibiome is designed to be formatted as a sachet supplement which can be mixed with warm water or a dairy product for ease of administration.
It can be taken both for prevention – ideally twice a year for three months – or as an adjuvant approach to be taken alongside antibiotics to prevent recurrences.
The product will be officially launched at Vitafoods Europe in Barcelona (5-7 May), with the goal of expanding commercialization to the rest of the world in the months following.
