Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

July 10, 2024 updated by: University Hospital, Antwerp

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: over the study period (= 13 months)
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
Time Frame: over the study period (= 13 months)
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
Time Frame: over the study period (= 13 months)
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
Time Frame: over the study period (= 13 months)
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
Time Frame: over the study period (= 13 months)
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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