RespiratoryNCT07378852
Integrated Study on Gut Microbiota, Immune Indicators, and Trace Elements in Children With Respiratory Tract Infections
An observational study of Respiratory, run by Min-Tze LIONG at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jan 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site
The 940th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
Lanzhou, Gansu, 730000
Yongli Dai, MD., (0931) 2938150, xbmdyxb163@163.com
Yan Xu, MD., (0931) 2938150, xbmdyxb163@163.com
Malaysia1 site
Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, 11800
Min Tze Liong, Ph.D., 6046532114, mintze.liong@usm.my
Yuan Jie, M.Sc., 86 198 2187 2781, peanut.yuan@diprobio.com
About this study
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.
Read the 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.
- Conditions
- Respiratory
- Keywords
- children, respiratory, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day-1
Secondary outcomes (2)
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.
Measured: Day-1
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
Measured: Day-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RespiratoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Collaborators
- 940 Hospital of the People's Liberation Army Joint Logistic Support Force
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Yongli Dai, MD., Principal investigator, 940 Hospital of the People's Liberation Army Joint Logistic Support Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378852
- Sponsor's protocol ID
- 2024KY22213
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Study on Gut Microbiota, Immune Indicators, and Trace Elements in Children With Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT07378852
- Acronym / sponsor ID
- 2024KY22213
- Conditions
- Respiratory
- Keywords
- children, respiratory, gut microbiota
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- 940 Hospital of the People's Liberation Army Joint Logistic Support Force
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Respiratory symptoms duration and frequency in all children cohorts as assessed using questionnaire
Time frame: Day-1
Gastrointestinal symptoms duration and frequency in all children cohorts as assessed using questionnaire
Time frame: Day-1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongli Dai, MD. principal investigator
940 Hospital of the People's Liberation Army Joint Logistic Support Force
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory, run by Min-Tze LIONG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Jie, M.Sc. (822137027899, peanut.yuan@diprobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota profiles of fecal samples in all children cohorts as assessed via metagenomics sequencing (time frame: Day-1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.