Clinical trial NCT06205966: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virus Diseases in Children
Lead sponsor: Szent Miklós Szolgálat Kft.
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 142
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 children aged six months to 5 years. The investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection.

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

Primary outcomes:
measure: Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)
timeFrame: 10 days
Secondary outcomes:
measure: Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired)
timeFrame: 10 days
measure: Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) recorded in a "Symptom Diary".
timeFrame: 10 days
measure: Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day.
timeFrame: 10 days
measure: Amount of NSAIDs used.
timeFrame: 10 days
measure: Number of children receiving antibiotic treatment in each treatment group.
timeFrame: 10 days
measure: Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the "Symptom Diary".
timeFrame: 10 days
measure: Number of unplanned medical visits (other than "Visit 1 and 2").
timeFrame: 10 days
measure: Days of absences from day care center/school.
timeFrame: 10 days
Other outcomes:
Locations:
city: Szigetszentmiklós
country: Hungary
facility: Szent Miklós Szolgálat Kft.
state: Pest
Study officials:
References:
citation: Maya-Barrios A, Lira-Hernandez K, Jimenez-Escobar I, Hernandez L, Ortiz-Hernandez A, Jimenez-Gutierrez C, Lopez-Velazquez G, Gutierrez-Castrellon P. Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial. Benef Microbes. 2021 Apr 12;12(2):137-145. doi: 10.3920/BM2020.0171. Epub 2021 Apr 1.