Cleft Palate Children, Otitis Media in Children
Conditions
Keywords
otitis media, upper respiratory tract microbiome, cleft palate, probiotics, Lacticaseibacillus rhamnosus GG
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbactiol Baby
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months
Sponsors
Universiteit Antwerpen
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* cleft palate & lip (uni/bilateral) or cleft palate * No syndromal disorders
Exclusion criteria
* syndromal disorder * history of ventilation tube placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of episodes of otorrea | over the study period (= 13 months) | Document the number and duration of episodes of otorrea after ventilation tube placement |
| Microbiome composition | over the study period (= 13 months) | Longitudinal study of the composition of the URT microbiome (alpha, beta diversity and individual taxa), more specific the oral cavity, rhinopharynx, and middle ears. Analysis will be done with 16S amplicon sequencing or shotgun sequencing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of probiotics on the composition of the URT microbiome | over the study period (= 13 months) | Longitudinal study of the effect of probiotics on the composition of the upper respiratory tract microbiome in children with cleft palate. This will be analysed by 16S amplicon sequencing or shotgun sequencing, and qPCR. |
| Transfer of bacteria | over the study period (= 13 months) | Follow-up of the transfer of orally administered probiotic bacteria to the upper respiratory tract (rhinopharynx, middle ears, oral cavity). Done with qPCR |
| Differences in abundances of lactic acid bacteria in control/probiotic treatment group | over the study period (= 13 months) | Analysis of the differences in abundances of lactic acid bacteria in the microbiome of patients with cleft palate with/without the administration of probiotics, done by sequencing and qPCR |
Countries
Belgium
Contacts
Primary ContactAn Boudewyns, Prof
Backup ContactJoke Van Malderen, Ir
Outcome results
None listed