Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-2
SponsorUniversity Hospital, Antwerp
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
cleft palate & lip (uni/bilateral) or cleft palate
No syndromal disorders
Disqualifiers
syndromal disorder
history of ventilation tube placement
Trial design
Design model
Parallel
Treatments tested in this trial
Probactiol Baby
Dietary supplementDietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Probiotic groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Antwerp
Lead sponsor
Universiteit Antwerpen
Collaborator
Source ClinicalTrials.gov