Clinical trial Recruiting at 1 site Interventional Ages 6 Months to 2

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.

More Cleft Lip and Palate trials

Quick facts

Study typeInterventional
Ages6 Months to 2 Years
SexAll
Enrollment40 (estimated)
SponsorUniversity Hospital, Antwerp
Academic / other
Locations1 site (Edegem, Antwerp)
StatusRecruiting
StartedJune 24, 2024
Main results expectedJune 24, 2026
Study endsJune 24, 2028
Registry record updatedJuly 17, 2024
Trial IDNCT06505330 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.