Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505330
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 The airway microbiome composition in children with cleft palates
2 Whether oral probiotics can reduce the number and duration of ear discharge episodes
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None