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NCT Number: NCT06505330

Respiratory Tract Microbiome and Probiotics 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.

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Key information

Conditions

Otitis Media in Children Cleft Palate Cleft Palate Children Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Ear Diseases Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location status: Recruiting

Location contact

An Boudewyns, Prof. Dr.

CONTACT

Joke Van Malderen, Ir.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • syndromal disorder
  • history of ventilation tube placement

Treatment and study plan

Probactiol Baby

Dietary Supplement

Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

An Boudewyns, Prof

CONTACT

[email protected]

003238214791

Joke Van Malderen, Ir

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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