Last updated: January 11, 2024
Sponsor: Milosevits Gergely
Overall Status: Active - Recruiting
Phase
N/A
Condition
Respiratory Syncytial Virus (Rsv) Infection
Treatment
Placebo
BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)
Clinical Study ID
NCT06205966
SzentMiklósSzolgálatKft.
Ages 4-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)
- Any gender
- Age from 4 years to 17 years
- Signing a informed consent form by at least one parent, foster parent or guardianafter patient information and by children aged over 6 years
- Negative Strep test
Exclusion
Exclusion Criteria:
- Use of antibiotics or probiotics in the 10 days prior to study enrolment
- Use of a probiotic other than the test sample during the study
- Eight or more otitis media within 12 months
- Two or more bacterial sinusitis within 12 months
- Two or more pneumonia episodes within 12 months
- History of two or more invasive infections (meningitis, cellulitis, osteomyelitis,septicaemia)
- Chronic diarrhea
- Recurrent deep skin or organ abscesses
- Persistent superficial candidiasis
- Use of antibiotics for two months or more to treat respiratory infections within 12months
- Gastroesophageal reflux
- Perennial (e.g., dust mite or mold) or current seasonal hay fever allergy
- Primary or secondary ciliary dyskinesia
- Congenital malformations of the respiratory tract
Study Design
Total Participants: 142
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
December 21, 2023
Estimated Completion Date:
November 30, 2025
Study Description
Connect with a study center
Szent Miklós Szolgálat Kft.
Szigetszentmiklós, Pest 2310
HungaryActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.