Respiratory Tract Microbiome and Probiotics 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

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.

Study Overview

• Status: Recruiting
• Conditions: Cleft Palate Children; Otitis Media in Children
• Intervention / Treatment: Dietary supplement: Probactiol Baby

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: An Boudewyns, Prof; Phone Number: 003238214791; Email: An.Boudewyns@uza.be
• Study Contact Backup: Name: Joke Van Malderen, Ir; Email: joke.vanmalderen@uantwerpen.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • University Hospital Antwerp
      • Contact: An Boudewyns, Prof. Dr.
      • Sub-Investigator: Joke Van Malderen, Ir.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• cleft palate & lip (uni/bilateral) or cleft palate
• No syndromal disorders

Exclusion Criteria:

• syndromal disorder
• history of ventilation tube placement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Probiotic group; Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Baby contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)	Dietary supplement: Probactiol Baby; Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome composition	Longitudinal study of the composition of the URT microbiome (alpha, beta diversity and individual taxa), more specific the oral cavity, rhinopharynx, and middle ears. Analysis will be done with 16S amplicon sequencing or shotgun sequencing.	over the study period (= 13 months)
Number of episodes of otorrea	Document the number and duration of episodes of otorrea after ventilation tube placement	over the study period (= 13 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of probiotics on the composition of the URT microbiome	Longitudinal study of the effect of probiotics on the composition of the upper respiratory tract microbiome in children with cleft palate. This will be analysed by 16S amplicon sequencing or shotgun sequencing, and qPCR.	over the study period (= 13 months)
Transfer of bacteria	Follow-up of the transfer of orally administered probiotic bacteria to the upper respiratory tract (rhinopharynx, middle ears, oral cavity). Done with qPCR	over the study period (= 13 months)
Differences in abundances of lactic acid bacteria in control/probiotic treatment group	Analysis of the differences in abundances of lactic acid bacteria in the microbiome of patients with cleft palate with/without the administration of probiotics, done by sequencing and qPCR	over the study period (= 13 months)

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2028

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: cleft palate; probiotics; otitis media; Lacticaseibacillus rhamnosus GG; upper respiratory tract microbiome
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Ear Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Otitis; Otitis Media
• Other Study ID Numbers: B3002024000099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No