Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate

NCT06505330 | Recruiting

• 1 other identifier: B3002024000099
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.The airway microbiome composition in children with cleft palates.
2. 2.Whether oral probiotics can reduce the number and duration of ear discharge episodes.

Conditions

Otitis Media in Children; Cleft Palate Children

Keywords

otitis media; upper respiratory tract microbiome; cleft palate; probiotics; Lacticaseibacillus rhamnosus GG

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Effect of probiotics on the composition of the URT microbiome

  over the study period (= 13 months)

• Transfer of bacteria

  over the study period (= 13 months)

• Differences in abundances of lactic acid bacteria in control/probiotic treatment group

  over the study period (= 13 months)

Study Arms (2)

Control group

NO INTERVENTION

Probiotic group

EXPERIMENTAL

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

Interventions

Probactiol Baby DIETARY_SUPPLEMENT

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

Probiotic group

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• syndromal disorder
• history of ventilation tube placement

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Otitis Media; Cleft Palate

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

An Boudewyns, Prof

CONTACT

003238214791; An.Boudewyns@uza.be

Joke Van Malderen, Ir

CONTACT

joke.vanmalderen@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2028
• Last Updated: July 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)