Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate
NCT Number: NCT06505330
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Otitis Media in Children|Cleft Palate Children
Interventions: DIETARY_SUPPLEMENT: Probactiol Baby
Sponsor: University Hospital, Antwerp
Collaborators: Universiteit Antwerpen
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-24
Completion Date: 2028-06-24
Locations: University Hospital Antwerp, Edegem, Antwerp, 2650, Belgium

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.

Primary Outcome Measures: Microbiome composition, 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., over the study period (= 13 months)|Number of episodes of otorrea, Document the number and duration of episodes of otorrea after ventilation tube placement, over the study period (= 13 months)
Secondary Outcome Measures: Effect of probiotics on the composition of the URT microbiome, 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., over the study period (= 13 months)|Transfer of bacteria, Follow-up of the transfer of orally administered probiotic bacteria to the upper respiratory tract (rhinopharynx, middle ears, oral cavity). Done with qPCR, over the study period (= 13 months)|Differences in abundances of lactic acid bacteria in control/probiotic treatment group, 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, over the study period (= 13 months)