About this trial
This observational study aims to investigate the characteristics of gut microbiota and their associations with immune and nutritional indicators in children with different respiratory health statuses. A total of 120 children will be enrolled and categorized into four groups: children with Mycoplasma pneumoniae pneumonia (MPP), children with acute respiratory tract infections without Mycoplasma pneumoniae (NMP), children with recurrent respiratory tract infections (RRTIs), and healthy controls. By comparing gut microbiota composition and diversity, as well as immune- and nutrition-related indicators across groups, this study seeks to clarify the potential role of intestinal dysbiosis and host immune-nutritional interactions in the pathogenesis and clinical manifestations of pediatric respiratory tract infections.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 3-14 years;
Good compliance and complete clinical data;
Guardians are informed and sign written consent;
MPP group: meets diagnostic criteria of Guidelines for Diagnosis and Treatment of Mycoplasma Pneumoniae Pneumonia in Children (2023 Edition);
Disqualifiers
Other infectious diseases (e.g., measles, pertussis, tuberculosis);
Congenital heart disease, immunodeficiency, or major organ dysfunction;
Use of antibiotics, probiotics, immunomodulators, hormones, or microecological preparations within the past 15-30 days;
Unqualified biological samples or incomplete laboratory data.
Trial population
Children from all cohorts will be recruited from the pediatric clinics of the 940th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Microbiota profiles of fecal samples in all children cohorts as assessed via metagenomics sequencing
Differences in microbiota abundance in fecal sample of children with respiratory diseases compared to healthy cohort
Secondary outcomes
Respiratory symptoms duration and frequency in all children cohorts as assessed using questionnaire
Changes in duration and frequency of respiratory illnesses symptoms from children with respiratory diseases and healthy cohort, via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms.
Gastrointestinal symptoms duration and frequency in all children cohorts as assessed using questionnaire
Changes in duration and frequency of gastrointestinal illnesses symptoms from children with respiratory diseases and healthy cohort, via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms
Sponsors and contacts
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Min-Tze LIONG
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Collaborator
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