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
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 2
Healthy Volunteers: f
View:

• cleft palate \& lip (uni/bilateral) or cleft palate

• No syndromal disorders

Locations
Other Locations
Belgium
University Hospital Antwerp
RECRUITING
Edegem
Contact Information
Primary
An Boudewyns, Prof
An.Boudewyns@uza.be
003238214791
Backup
Joke Van Malderen, Ir
joke.vanmalderen@uantwerpen.be
Time Frame
Start Date: 2024-06-24
Estimated Completion Date: 2028-06-24
Participants
Target number of participants: 40
Treatments
No_intervention: Control group
Experimental: Probiotic group
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Baby contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
Sponsors
Leads: University Hospital, Antwerp
Collaborators: Universiteit Antwerpen

This content was sourced from clinicaltrials.gov