Integrated Study on Gut Microbiota, Immune Indicators, and Trace Elements in Children With Respiratory Tract Infections

ConditionRespiratory
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-14
SponsorMin-Tze LIONG

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 4 trial groups
Group A: Mycoplasma pneumoniae pneumonia (MPP) group
Group B: Non-mycoplasma acute respiratory tract infection (NMP) group
Group C: Recurrent respiratory tract infections (RRTIs) group
Group D: Healthy control group

Trial outcomes

Primary outcomes

1

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

Time frame
Day-1

Secondary outcomes

1

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.

Time frame
Day-1
2

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

Time frame
Day-1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Min-Tze LIONG

Lead sponsor

Universiti Sains Malaysia

Sponsor institution

940 Hospital of the People's Liberation Army Joint Logistic Support Force

Collaborator

This trial is not recruiting at the moment. You can still explore other options: