Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

Otitis media with effusion (OME) involves fluid accumulation in the middle ear without infection, sometimes causing discomfort and hearing loss in children. Persistent middle ear fluid lasting over 3 months may require treatment, including placement of ventilation tubes if it affects hearing. Children with a cleft palate are at higher risk for otorrea after ventilation tube placement. Treatment typically involves antibiotic drops and ear cleaning by an ENT doctor, often requiring repeated visits, which may impact quality of life for both the child and the parents. The mouth, throat, and nose harbor bacteria that can influence ear infections. This study aims to determine if probiotics can alter the bacteria in the nasopharynx and middle ear fluid and reduce the number of episodes of eardischarge following ventilation tube placement in children with cleft palate. Using Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 from Bactiol® Baby (Metagenics), patients will be divided into two groups: one receiving probiotic drops and one not. The study will assess if probiotics can reduce the number of episodes with ear discharge in children with cleft palate, by examining the following: 1. The airway microbiome composition in children with cleft palates. 2. Whether oral probiotics can reduce the number and duration of ear discharge episodes.

NCT Number	NCT06505330
Lead Sponsor	University Hospital, Antwerp Collaborators: Universiteit Antwerpen
Conditions	Otitis Media in Children, Cleft Palate Children
Enrollment	40 participants
Start Date	2024-06-24
Primary Completion	2026-06-24 (estimated)
Study Completion	2028-06-24 (estimated)
Updated on ClinicalTrials.gov	2024-07-17