Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate
NCT ID: NCT06505330
Last Updated: 2024-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-06-24
2028-06-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control group
No interventions assigned to this group
Probiotic group
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Baby contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
Probactiol Baby
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months
Interventions
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Probactiol Baby
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months
Eligibility Criteria
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Inclusion Criteria
* No syndromal disorders
Exclusion Criteria
* history of ventilation tube placement
6 Months
2 Years
ALL
No
Sponsors
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Universiteit Antwerpen
OTHER
University Hospital, Antwerp
OTHER
Responsible Party
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Locations
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University Hospital Antwerp
Edegem, Antwerp, Belgium
Countries
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Central Contacts
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Facility Contacts
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An Boudewyns, Prof. Dr.
Role: primary
Other Identifiers
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B3002024000099
Identifier Type: -
Identifier Source: org_study_id
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