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

February 1, 2026 updated by: Min-Tze LIONG
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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Respiratory tract infections remain one of the leading causes of morbidity in children. Among them, Mycoplasma pneumoniae pneumonia (MPP) and recurrent respiratory tract infections (RRTIs) represent two clinically important yet mechanistically heterogeneous disease patterns. The former is characterized by acute inflammatory responses and immune dysregulation, whereas the latter reflects long-term susceptibility, immune imbalance, and repeated infectious episodes.

In recent years, the gut microbiota has been recognized as a critical regulator of systemic immunity through the gut-lung axis. Alterations in intestinal microbial composition have been implicated in respiratory infection susceptibility, inflammatory regulation, and immune maturation in children. In parallel, essential trace elements such as zinc and iron play indispensable roles in maintaining mucosal barrier integrity, immune function, and microbial homeostasis. However, integrated evidence linking gut microbiota characteristics, immune-related indicators, and trace element status across different pediatric respiratory disease phenotypes remains limited.

Therefore, this study adopts a prospective observational case-control design. From November 2024 to June 2026, a total of 120 children aged 3-14 years will be enrolled and divided equally into four groups (30 participants per group), namely mycoplasma pneumoniae pneumonia (MPP) group, non-mycoplasma acute respiratory tract infection (NMP) group, recurrent respiratory tract infections (RRTIs) group, and healthy control group.

Clinical information and fecal samples will be collected according to standardized procedures. Gut microbiota composition and diversity will be analyzed using fecal samples, while immune- and nutrition-related indicators will be assessed in accordance with established laboratory protocols. Comparative and correlation analyses will be conducted to explore disease-specific microbial and host response patterns.

This integrated study aims to provide a comprehensive biological basis for understanding pediatric respiratory infections and to support future strategies involving microbiota modulation, nutritional intervention, and immune regulation.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The 940th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yongli Dai, MD.
        • Principal Investigator:
          • Yan Xu, MD.
  • Malaysia
    • Pulau Pinang
      • Pulau Pinang, Pulau Pinang, Malaysia, 11800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

Description

Inclusion Criteria

  1. Aged 3-14 years;
  2. Good compliance and complete clinical data;
  3. Guardians are informed and sign written consent;
  4. MPP group: meets diagnostic criteria of Guidelines for Diagnosis and Treatment of Mycoplasma Pneumoniae Pneumonia in Children (2023 Edition);
  5. NMP group: acute respiratory tract infection with negative MP-DNA/RNA;
  6. RRTIs group: meets diagnostic criteria of Clinical Diagnosis and Treatment Pathway for Recurrent Respiratory Tract Infections in Children (2022 Edition);
  7. Healthy controls: no respiratory infection history within the past month.

Exclusion Criteria

  1. Other infectious diseases (e.g., measles, pertussis, tuberculosis);
  2. Congenital heart disease, immunodeficiency, or major organ dysfunction;
  3. Use of antibiotics, probiotics, immunomodulators, hormones, or microecological preparations within the past 15-30 days;
  4. Unqualified biological samples or incomplete laboratory data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiota profiles of fecal samples in all children cohorts as assessed via metagenomics sequencing
Time Frame: Day-1
Differences in microbiota abundance in fecal sample of children with respiratory diseases compared to healthy cohort
Day-1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory symptoms duration and frequency in all children cohorts as assessed using questionnaire
Time Frame: Day-1
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.
Day-1
Gastrointestinal symptoms duration and frequency in all children cohorts as assessed using questionnaire
Time Frame: Day-1
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
Day-1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min-Tze LIONG

Collaborators

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

Investigators

  • Principal Investigator: Yongli Dai, MD., The 940th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024KY22213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe