Integrated Study on Gut Microbiota, Immune Indicators, and Trace Elements in Children With Respiratory Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Microbiota profiles of fecal samples in all children cohorts as assessed via metagenomics sequencing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
Mycoplasma pneumoniae pneumonia (MPP) group
Children with Mycoplasma pneumoniae pneumonia
结局指标
主要结局
Microbiota profiles of fecal samples in all children cohorts as assessed via metagenomics sequencing
时间窗: Day-1
Differences in microbiota abundance in fecal sample of children with respiratory diseases compared to healthy cohort
次要结局
- 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)
研究者
Min-Tze LIONG
Prof.
Universiti Sains Malaysia