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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
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.
Age
0 - 2 years
Sex
ALL
Healthy Volunteers
No
University Hospital Antwerp
Edegem, Antwerp, Belgium
Start Date
June 24, 2024
Primary Completion Date
June 24, 2026
Completion Date
June 24, 2028
Last Updated
July 17, 2024
40
ESTIMATED participants
Probactiol Baby
DIETARY_SUPPLEMENT
Lead Sponsor
University Hospital, Antwerp
Collaborators
Data Source & Attribution
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