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Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

NCT06505330 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-17

No results posted yet for this study

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.

Conditions

  • Otitis Media in Children
  • Cleft Palate Children

Interventions

DIETARY_SUPPLEMENT

Probactiol Baby

Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months

Sponsors & Collaborators

  • Universiteit Antwerpen

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2026-06-24
Completion
2028-06-24

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505330 on ClinicalTrials.gov