Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probactiol Baby.
- Who it may be relevant to
- Registry conditions: Otitis Media in Children, Cleft Palate Children. Basic parameters: 6 months — 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of the Effects of Probiotics on the Upper Respiratory Tract Microbiome and the Prevention of Otitis Media With Effusion in Children With Cleft Palate
Overview
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.
Interventions
- Dietary supplement Probactiol Baby
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months
Primary outcome measures
- Microbiome composition [Time frame: over the study period (= 13 months)]
- Number of episodes of otorrea [Time frame: over the study period (= 13 months)]
Secondary outcome measures (3)
- Effect of probiotics on the composition of the URT microbiome [Time frame: over the study period (= 13 months)]
- Transfer of bacteria [Time frame: over the study period (= 13 months)]
- Differences in abundances of lactic acid bacteria in control/probiotic treatment group [Time frame: over the study period (= 13 months)]
Eligibility criteria
Inclusion criteria
- cleft palate \& lip (uni/bilateral) or cleft palate
- No syndromal disorders
Exclusion criteria
- syndromal disorder
- history of ventilation tube placement
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- University Hospital Antwerp — Edegem
Identifiers
NCT: NCT06505330 · B3002024000099