Recurrent Respiratory Tract Infection
Conditions
Interventions
Intervention Group:In addition to conventional treatment (which may include bacterial lysates or other immunomodulatory drugs for prevention, with proven efficacy beyond acute-phase management. For RR
?Maintenance phase: 6 drops/day.Administration should start on the first day of probiotic use and continue continuously for 8 weeks.
Control Group:Receive conventional treatment such as anti-infective therapy and symptomatic management, with no probiotics administered during the treatment period. A placebo (identical in appearance
Sponsors
The Sixth Affiliated Hospital,Sun Yat-sen University Yuexi Hospital/Xinyi City People's Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 6 Years
Inclusion criteria
Inclusion criteria: 1.Age < 6 years, with no gender restrictions; 2.Meets the clinical diagnostic criteria for recurrent respiratory tract infections as outlined in the Clinical Diagnostic and Treatment Pathway for Recurrent Respiratory Tract Infections in Children (2022 Edition); 3.Parents or other legally authorized guardians fully understand the trial and voluntarily sign an informed consent form before any study procedures begin; 4.Willing to discontinue the use of other probiotics during the trial period; 5.Agrees to provide stool biological samples during the trial period.
Exclusion criteria
Exclusion criteria: 1.Participants deemed by the investigator to have poor compliance or be unsuitable for participation; 2.Allergic reaction to the investigational product or its components; 3.Allergic reaction to respiratory infection medications or their components; 4.Respiratory infections caused by primary immunodeficiency disorders, acquired immunodeficiency syndrome (AIDS), 5.congenital respiratory malformations, congenital heart disease, gastroesophageal reflux disease (GERD), abnormal lung development, or other underlying medical conditions; 5.Severe malnutrition, rickets, or presence of severe primary diseases affecting the cardiac, neurological, hepatic, renal, or hematopoietic systems; 6.Critically ill patients; 7.Use of probiotic preparations, antibiotics, immunostimulatory agents, or immunosuppressants within 4 weeks prior to trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Severity of Respiratory Symptoms; | — |
Countries
China
Contacts
Public ContactSitao Li
The Sixth Affiliated Hospital,Sun Yat-sen University Yuexi Hospital/Xinyi City People's Hospital
Outcome results
None listed