An interventional study of Probactiol Baby in Otitis Media in Children and Cleft Palate Children, sponsored by University Hospital, Antwerp. Recruiting at 1 site in Belgium. Open to participants aged 6 Months to 2 Years. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Prevention
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:
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 40 is below the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Baby contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
Dietary Supplement: Probactiol Baby
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months
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.
Time frame: over the study period (= 13 months)
Number of episodes of otorrea
Document the number and duration of episodes of otorrea after ventilation tube placement
Time frame: over the study period (= 13 months)
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.
Time frame: 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
Time frame: 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
Time frame: over the study period (= 13 months)
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2026, 24 months after the start.
Of 36 non-industry interventional studies with no phase under Otitis Media, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 64. This study's planned 24 months is below that.
Counting every sponsor, half of 45 studies reached it within 38 months; a quarter within 13 and three quarters within 51.
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