NCT06505330

Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 6 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Otitis Media in Children
• Cleft Palate Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probactiol Baby	Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months

Timeline

• Start date: 2024-06-24
• Primary completion: 2026-06-24
• Completion: 2028-06-24
• First posted: 2024-07-17
• Last updated: 2024-07-17

Locations

1 site across 1 country: Belgium