Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Cleft Palate Children; Otitis Media in Children

Treatments: Dietary Supplement: Probactiol Baby

Study type: Interventional

Funder types: Other

Identifiers

NCT06505330

B3002024000099

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 months to 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• syndromal disorder
• history of ventilation tube placement

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Control group

No Intervention group

Probiotic group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probactiol Baby