- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07705685
National Cohort Study on Infant Gut Microbiota and Nutrition
Study on Gut Microbiota Characteristics and Their Relationship With Nutritional Health in Infants and Young Children Based on a National Cohort
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The human gastrointestinal tract harbors vast and diverse microbial communities collectively termed the "gut microbiota", widely known as the human body's "second genome". Research has demonstrated that during the colonization and maturation of gut microbiota in early infancy, these microbes participate in multiple core physiological processes including immune system maturation, nutrient absorption and metabolism, and nervous system development. Infancy represents a critical window for the establishment of intestinal microecology. Disturbances from adverse environmental factors such as antibiotic administration, inappropriate dietary patterns, and environmental pollution may trigger dysbiosis of microbial composition, which in turn elevates the long-term risk of developing obesity, allergic disorders, asthma, autism spectrum disorders and other diseases.
The formation and dynamic shifts of childhood gut microbiota are shaped not only by early-life exposures including mode of delivery, breastfeeding status and antibiotic use, but also by subsequent dietary patterns, living environments and socioeconomic status. For instance, high-fat diets reduce the abundance of beneficial gut bacteria, whereas Mediterranean-style diets support intestinal health; antibiotic treatment markedly diminishes microbial diversity and impairs community stability; urban-rural disparities also drive profound differences in gut microbial composition.
To date, domestic research on gut microbiota among infants and children has largely consisted of regional, small-cohort studies, lacking large-scale baseline datasets covering diverse geographic regions, age brackets and health statuses across China. This gap partially hinders the accumulation of scientific evidence for pediatric intestinal health research and disease prevention and control, and restricts the formulation of localized nutritional intervention strategies.
Accordingly, this study aims to conduct a large-cohort investigation covering infants and children aged 0 to 6 years nationwide. Through metagenomic sequencing and microbial isolation and culture of fecal specimens, we will construct gut microbiota atlases stratified by age, geographic region and health profile. The research will focus on associations between representative core gut taxa (e.g., Bifidobacterium) and indicators including children's nutritional status, immune development, allergic manifestations, gastrointestinal function and physical growth. We will also characterize microbial succession patterns during critical developmental windows in early life. Multivariate modeling and machine learning algorithms will be applied to screen microbial biomarkers strongly correlated with specific health conditions, and further dissect their underlying biological mechanisms.
This project is led by a professional research team with extensive experience in intestinal microecology. The team has previously completed gut microbiota profiling and analysis for thousands of infant subjects, obtained ethical approval and secured third-party laboratory qualification, laying a solid research foundation. Findings from this study will provide data support for early identification and intervention of common childhood illnesses, and deliver vital scientific evidence for developing personalized nutritional and health management strategies tailored to gut microecological signatures in Chinese children.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Shanghai, China
- DiPROBIO(Shanghai) Co., Ltd.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Infants and children aged 0-6 years, regardless of gender.
- Volunteers willing to participate in fecal sample collection and baseline health information gathering during the study period.
- Legal guardians must agree to participate in the study and provide a signed written informed consent.
Exclusion Criteria:
- Presence of congenital developmental anomalies, including but not limited to congenital cardiovascular malformations and chromosomal aneuploidy.
- Immune system functional disorders, such as Severe Combined Immunodeficiency.
- Diagnosis of hereditary diseases, such as genetic disorders caused by chromosomal abnormalities.
- Any condition deemed unsuitable for participation by the investigator, including but not limited to failure to meet compliance assessment standards.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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National cohort of Chinese children aged 0-6 years
This single nationwide cohort enrolls a total of 106,667 Chinese infants and children under 6 years old.
enrollment.
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This study is purely observational with no therapeutic or invasive clinical interventions implemented.
We only collect non-invasive fecal specimens from enrolled healthy infants and children aged 0-6 years across China, perform microbial genome sequencing and microbial isolation culture to analyze gut microbiota characteristics, and construct a national pediatric gut microbiome atlas.
No drugs, medical devices or clinical treatment adjustments are given to participants throughout the research.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Establish a national gut microbiome atlas of infants and children aged 0-6 years covering all 34 provincial-level administrative regions in China, incorporating subjects across distinct age brackets and geographic backgrounds
Prazo: Baseline (single time point at enrollment)
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Baseline (single time point at enrollment)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Qinghua Yu, DiproBio (Shanghai) Co., Ltd.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- SECCR2025-158-01
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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Boston Medical CenterRescindidoTeste Imunoquímico FecalEstados Unidos
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