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

Milosevits Gergely

Status: Enrolling

Conditions: Virus Diseases in Children

Treatments: Other: Placebo; Dietary Supplement: BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)

Study type: Interventional

Funder types: Other

Identifiers

NCT06205966

SzentMiklósSzolgálatKft.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Description:

Study product containing L. reuteri (PTA5289 and DSM 17938) taken orally once in the morning and once in the evening, each time 5 drops.

Treatment:

Dietary Supplement: BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)

Placebo

Placebo Comparator group

Description:

Placebo taken orally once in the morning and once in the evening, each time 5 drops.

Treatment:

Other: Placebo