Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT07297966
Eligibility Criteria:
Inclusion Criteria:
* Age \< 6 years, gender not limited;
* Meets the clinical diagnostic criteria for recurrent respiratory tract infections (Clinical Diagnosis and Treatment Pathway for Recurrent Respiratory Tract Infections in Children (2022 Edition) 10 );
* Parents or other legal guardians of the child fully understand the trial and voluntarily sign informed consent forms before the start of any research procedure;
* Willing to discontinue the use of other probiotics during the trial;
* Agree to the collection of fecal biological samples during this trial.
Exclusion Criteria:
* Those deemed by the investigator to have poor compliance or be unsuitable for participation;
* Allergic to the investigational product and its components;
* Allergic to respiratory tract infection drugs and their components;
* Respiratory infections caused by underlying diseases such as primary immunodeficiency diseases, acquired immunodeficiency syndrome (ADRS), congenital airway malformations, congenital heart disease, gastroesophageal reflux disease (GERD), and pulmonary dysplasia;
* Patients with severe malnutrition, rickets, and severe primary diseases of the heart, brain, liver, kidney, and hematopoietic systems;
* Use probiotic preparations, antibiotics, immunostimulants, or immunosuppressants 4 weeks before participating in the experiment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
6 Years
Study:
NCT07297966
Study Brief:
Protocol Section:
NCT07297966