Using probiotics to improve ear health in children with cleft palate
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
This study tests whether giving probiotics to children with cleft palate can help improve their ear health and reduce ear problems after they get ventilation tubes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Months to 2 Years |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06505330 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of probiotics on the upper respiratory tract microbiome in children with cleft palate who are at risk for otitis media. Specifically, it aims to determine if administering Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 can alter the bacterial composition in the nasopharynx and reduce the frequency of ear discharge after ventilation tube placement. The study will involve children diagnosed with cleft palate and will monitor their ear health over time. The approach seeks to provide a non-invasive treatment option that could improve quality of life for affected children and their families.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with cleft palate or cleft lip without associated syndromal disorders.
Not a fit: Patients with syndromal disorders or a history of ventilation tube placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a novel probiotic treatment that reduces ear infections and improves hearing outcomes in children with cleft palate.
How similar studies have performed: While the use of probiotics in similar contexts is emerging, this specific approach targeting the microbiome in children with cleft palate is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * cleft palate \& lip (uni/bilateral) or cleft palate * No syndromal disorders Exclusion Criteria: * syndromal disorder * history of ventilation tube placement
Where this trial is running
Edegem, Antwerp
- University Hospital Antwerp — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Study coordinator: An Boudewyns, Prof
- Email: An.Boudewyns@uza.be
- Phone: 003238214791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.