Trials / Completed
CompletedNCT03277820
Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
Effect of Probiotics on Microbiome of Adenoid Tissue and Middle Ear Fluid of Children With Otitis Media With Effusion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- University Hospital, Antwerp · Academic / Other
- Sex
- All
- Age
- 2 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to investigate whether the microbiota in the upper respiratory tract (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probactiol Mini | 6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12) |
Timeline
- Start date
- 2017-04-03
- Primary completion
- 2021-04-30
- Completion
- 2021-04-30
- First posted
- 2017-09-11
- Last updated
- 2021-04-30
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03277820. Inclusion in this directory is not an endorsement.