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

Launched by MILOSEVITS GERGELY · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how certain probiotics, specifically Lactobacillus reuteri strains, can help reduce symptoms of viral upper respiratory infections in children. These infections often cause symptoms like coughing, sneezing, a runny nose, and fever. The study is open to children between the ages of 4 and 17 who are experiencing these symptoms, as long as they have not taken antibiotics or other probiotics in the last 10 days and have a negative test for strep throat.

If your child is eligible and decides to participate, they will receive either the probiotic or a placebo (a treatment with no active ingredients) to see how it affects their symptoms. Parents or guardians will need to provide consent for their child's participation, and children over 6 years old will also be asked to agree to join. This trial aims to understand if these probiotics can make a difference in how children feel when they have these common viral infections.

Gender

ALL

Eligibility 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