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

NCT07378852 | Not Yet Recruiting

• 1 other identifier: 2024KY22213
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Respiratory

Keywords

children; respiratory; gut microbiota

Outcome Measures

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

  Day-1

Secondary Outcomes (2)

• Respiratory symptoms duration and frequency in all children cohorts as assessed using questionnaire

  Day-1

• Gastrointestinal symptoms duration and frequency in all children cohorts as assessed using questionnaire

  Day-1

Study Arms (4)

Mycoplasma pneumoniae pneumonia (MPP) group

Children with Mycoplasma pneumoniae pneumonia

Non-mycoplasma acute respiratory tract infection (NMP) group

Children with acute respiratory tract infection without Mycoplasma pneumoniae

Recurrent respiratory tract infections (RRTIs) group

Children with recurrent respiratory tract infections

Healthy control group

Healthy children without any respiratory disease

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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);
• NMP group: acute respiratory tract infection with negative MP-DNA/RNA;
• RRTIs group: meets diagnostic criteria of Clinical Diagnosis and Treatment Pathway for Recurrent Respiratory Tract Infections in Children (2022 Edition);
• Healthy controls: no respiratory infection history within the past month.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Min-Tze LIONG: lead
• The 940th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army: collaborator

Study Sites (2)

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

Lanzhou, Gansu, 730000, China

Location

Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, 11800, Malaysia

Location

Study Officials

• Yongli Dai, MD.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Jie, M.Sc.

CONTACT

822137027899; peanut.yuan@diprobio.com

Min Tze Liong, Ph.D.

CONTACT

6046532114; mintze.liong@usm.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); MY (1)