Study of the Effects of Probiotics on the Upper Respiratory Tract Microbiome and the Prevention of Otitis Media With Effusion in Children With Cleft Palate

What this Trial Is About

Otitis media with effusion (OME) is a condition where fluid builds up in the middle ear without infection, sometimes causing discomfort and hearing loss in young children. This condition can last over three months and may need treatment such as ventilation tube placement if it affects hearing. Children with cleft palate are more likely to experience ear discharge after tube placement, and this study aims to see if probiotics can change the bacteria in the nose and middle ear to reduce these episodes in children with cleft palate. Participants will be divided into two groups: one group will receive probiotic drops containing Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 (Probactiol Baby), while the other group will not receive probiotics. The probiotic drops are given daily for 13 months. The study will monitor changes in the airway microbiome and whether probiotics reduce the number and length of ear discharge episodes in children with cleft palate. During the 13-month study, researchers will collect samples to analyze the microbiome composition and track episodes of ear discharge. They will evaluate the presence and transfer of bacteria, especially lactic acid bacteria, between groups. Parents and children will attend regular visits for monitoring, and the study will carefully observe the effects of probiotics on ear health and the respiratory tract over this period.

Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate