Status:
RECRUITING
A Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children
Lead Sponsor:
Milosevits Gergely
Conditions:
Virus Diseases in Children
Eligibility:
All Genders
4-17 years
Phase:
NA
Brief Summary
This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.
Detailed Description
Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in chil...
Eligibility Criteria
Inclusion
- 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 guardian after patient information and by children aged over 6 years
- Negative Strep test
Exclusion
- 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 12 months
- 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
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06205966
Start Date
December 21 2023
End Date
November 30 2025
Last Update
January 16 2024
Active Locations (1)
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1
Szent Miklós Szolgálat Kft.
Szigetszentmiklós, Pest County, Hungary, 2310