Using probiotics to improve ear health in children with cleft palate
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
Run by University Hospital, Antwerp · NCT06505330 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 2 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Status | Recruiting |
| Started | June 24, 2024 |
| Main results expected | June 24, 2026 |
| Study ends | June 24, 2028 |
| Registry record updated | July 17, 2024 |
| Trial ID | NCT06505330 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children diagnosed with cleft palate or cleft lip without associated syndromal disorders.
✕Probably not a fit
Patients with syndromal disorders or a history of ventilation tube placement may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
University Hospital Antwerp
Edegem, Antwerp, Belgium Recruiting
Study contacts
- Study coordinator: An Boudewyns, Prof
- Email: An.Boudewyns@uza.be
- Phone: 003238214791
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Perceptions of High and Low Intensity Speech Intervention in Children with a Cleft Palate
This study looks at how providers and children with cleft palate and their parents feel about high- versus low-intensity speech therapy to see which is more acceptable and helpful.
-
CLiKX Tympanostomy Tube Delivery System for Ear Tube Placement
A device is being tested to place ear tubes in both children and adults to see if it can be safely and effectively position the tube during tympanostomy procedures.
-
Suprazygomatic maxillary nerve block to reduce pain and shorten hospital stay after cleft palate repair in children
This project tries a suprazygomatic maxillary nerve block in children having cleft palate repair to see if they need less morphine and can go home sooner.
-
Comparing high and low intensity speech therapy for children with cleft palate
This study is testing whether more frequent speech therapy sessions help Belgian Dutch-speaking children with cleft palate improve their speech and overall quality of life better than fewer sessions over a longer time.
-
Training infants with cleft palate to use signs for better speech development
This study tests whether teaching one-year-old children with cleft palate to use signs along with talking can help them develop better speech skills.
-
Universal newborn hearing screening in Kenya using smartphone tests
This study tests whether smartphone hearing screening can help identify ear infections and hearing loss in infants, including those exposed to HIV, over 6 months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.