Investigating probiotics for viral respiratory infections in children
A Randomized, Double Blind, Placebo-controlled 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
NA · Szent Miklós Szolgálat Kft. · NCT06205966
This study is testing if two types of probiotics can help children aged 4 to 17 feel better when they have viral respiratory infections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Szent Miklós Szolgálat Kft. (other) |
| Locations | 1 site (Szigetszentmiklós, Pest) |
| Trial ID | NCT06205966 on ClinicalTrials.gov |
What this trial studies
This study examines the effects of two specific strains of Lactobacillus reuteri probiotics on symptoms associated with viral upper respiratory tract infections in children aged 4 to 17 years. The research aims to build on previous findings that indicated a reduction in febrile days and pain severity in younger children. By expanding the age range and increasing the number of participants, the study seeks to provide more comprehensive data on the efficacy of these probiotics. Participants will receive either the probiotic treatment or a placebo to assess the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 17 years experiencing symptoms of upper respiratory tract infections.
Not a fit: Patients with a history of recurrent bacterial infections or those who have recently used antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-antibiotic treatment option to alleviate symptoms of viral upper respiratory infections in children.
How similar studies have performed: Previous studies have shown positive outcomes with similar probiotic approaches, suggesting potential for success in this investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 guardian after patient information and by children aged over 6 years * Negative Strep test 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 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
Where this trial is running
Szigetszentmiklós, Pest
- Szent Miklós Szolgálat Kft. — Szigetszentmiklós, Pest, Hungary (RECRUITING)
Study contacts
- Study coordinator: Gergely Milosevits, MD, PhD
- Email: drgergelymilosevits@gmail.com
- Phone: +36308425722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Virus Diseases in Children