Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

Not Applicable

Recruiting

• Conditions: Cleft Palate Children; Otitis Media in Children
• Interventions: Dietary Supplement: Probactiol Baby

• Registration Number: NCT06505330
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-24
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Primary Completion: 2026-06-24
• Study Completion: 2028-06-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• cleft palate & lip (uni/bilateral) or cleft palate
• No syndromal disorders

Exclusion Criteria

• syndromal disorder
• history of ventilation tube placement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Probactiol Baby	Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Baby contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium