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NCT03277820
Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
NA trial testing Probactiol Mini in Otitis Media With Effusion in 37 participants. Completed in 30 April 2021.
30 April 2021
Quick facts
| Lead sponsor | University Hospital, Antwerp |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 37 |
| Start date | 3 April 2017 |
| Primary completion | 30 April 2021 |
| Estimated completion | 30 April 2021 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Probactiol Mini
Conditions studied
- Otitis Media With Effusion — all drugs for Otitis Media With Effusion →
- Probiotics — all drugs for Probiotics →
- Adenoid Vegetations — all drugs for Adenoid Vegetations →
Sponsor
University Hospital, Antwerp
Who can join
Adults 2 to 12, any sex, with Otitis Media With Effusion or Probiotics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03277820
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Otitis Media With Effusion
Currently open trials in the same condition.
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Other University Hospital, Antwerp trials
Trials by the same sponsor.
- NCT07455422 — A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurr · NA · not yet recruiting
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- NCT07443761 — Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital. · active not recruiting
- NCT06372847 — DISE-HNS Effect Study · NA · recruiting
- NCT07189091 — CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03277820 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Antwerp
- Last refreshed: 30 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03277820.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing