Otitis Media in ChildrenNCT06505330
Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate
A study testing Probactiol Baby in people with Otitis Media in Children and Cleft Palate Children, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Otitis Media in Children, Cleft Palate Children
- What is being tested?
- Probactiol Baby
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jun 2024to 24 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cleft palate \& lip (uni/bilateral) or cleft palate
- No syndromal disorders
Who cannot join
- syndromal disorder
- history of ventilation tube placement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joke Van Malderen, Ir contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
An Boudewyns, Prof. Dr.
Joke Van Malderen, Ir.
About this study
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
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.
Read more
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:
- The airway microbiome composition in children with cleft palates.
- Whether oral probiotics can reduce the number and duration of ear discharge episodes.
- Conditions
- Otitis Media in Children, Cleft Palate Children
- Being tested
- Probactiol Baby
- Keywords
- otitis media, upper respiratory tract microbiome, cleft palate, probiotics, Lacticaseibacillus rhamnosus GG
- Medical subject headings
- Otitis Media, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probactiol BabyDietary supplement
Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Probiotic group | Experimental | Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Baby contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12) Receives: Dietary Supplement: Probactiol Baby |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over the study period (= 13 months)
Number of episodes of otorrea
Document the number and duration of episodes of otorrea after ventilation tube placement
Measured: over the study period (= 13 months)
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: over the study period (= 13 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start24 Jun 2024
- Primary completion24 Jun 2026 (estimated)
- Study completion24 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505330
- Sponsor's protocol ID
- B3002024000099
- Status last verified
- Jun 2024
- First submitted
- 10 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06505330
- Acronym / sponsor ID
- B3002024000099
- Conditions
- Otitis Media in Children, Cleft Palate Children
- Keywords
- otitis media, upper respiratory tract microbiome, cleft palate, probiotics, Lacticaseibacillus rhamnosus GG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 24 Jun 2026 (estimated)
- Study completion
- 24 Jun 2028 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The airway microbiome composition in children with cleft palates.
- Whether oral probiotics can reduce the number and duration of ear discharge episodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Probiotic group | Experimental | Dietary Supplement: Probactiol BabyDietary Supplement: Probactiol Mini 6 droplets of Probactiol Baby contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12) |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- cleft palate \& lip (uni/bilateral) or cleft palate
- No syndromal disorders
Key exclusion criteria (2 listed)
- syndromal disorder
- history of ventilation tube placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probactiol BabyDietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months | Dietary supplement | Probiotic group |
Primary outcome
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.
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
3 secondary outcomes
Effect of probiotics on the composition of the URT microbiome
Time frame: over the study period (= 13 months)
Transfer of bacteria
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joke Van Malderen, Ir contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probactiol Baby in people with Otitis Media in Children and Cleft Palate Children, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact An Boudewyns, Prof (003238214791, An.Boudewyns@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome composition (time frame: over the study period (= 13 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.