NCT06505330 Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate
| NCT ID | NCT06505330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Otitis Media in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2026-06-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-06-24 with a primary completion date of 2026-06-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * cleft palate \& lip (uni/bilateral) or cleft palate * No syndromal disorders Exclusion Criteria: * syndromal disorder * history of ventilation tube placement
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06505330 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 2 Years, studying Otitis Media in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06505330 currently recruiting?
Yes, NCT06505330 is actively recruiting participants. Contact the research team at An.Boudewyns@uza.be for enrollment information.
Where is the NCT06505330 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06505330 clinical trial?
NCT06505330 is sponsored by University Hospital, Antwerp. The trial plans to enroll 40 participants.