Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

National Cohort Study on Infant Gut Microbiota and Nutrition

10 de julio de 2026 actualizado por: DiproBio (Shanghai) Co., Ltd.

Study on Gut Microbiota Characteristics and Their Relationship With Nutritional Health in Infants and Young Children Based on a National Cohort

This study plans to collect 106,667 fecal samples from Chinese infants and children under 6 years old, with multi-dimensional stratification based on geographic location, mode of delivery, antibiotic exposure, and developmental stage. Fecal gut microbiota will be profiled to construct a gut microbiome atlas, establish quantitative analytical models linking geographic regions, physiological phenotypes and microbial signatures, and identify key microbial biomarkers associated with core healthy phenotypes.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Descripción detallada

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 estudio

De observación

Inscripción (Estimado)

106667

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Shanghai, Porcelana
        • DiPROBIO(Shanghai) Co., Ltd.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

A total of 106,667 Chinese infants and children aged 0 to 6 years will be enrolled across all 34 provincial-level administrative regions of China

Descripción

Inclusion Criteria:

  1. Infants and children aged 0-6 years, regardless of gender.
  2. Volunteers willing to participate in fecal sample collection and baseline health information gathering during the study period.
  3. Legal guardians must agree to participate in the study and provide a signed written informed consent.

Exclusion Criteria:

  1. Presence of congenital developmental anomalies, including but not limited to congenital cardiovascular malformations and chromosomal aneuploidy.
  2. Immune system functional disorders, such as Severe Combined Immunodeficiency.
  3. Diagnosis of hereditary diseases, such as genetic disorders caused by chromosomal abnormalities.
  4. Any condition deemed unsuitable for participation by the investigator, including but not limited to failure to meet compliance assessment standards.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
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
Periodo de tiempo: Baseline (single time point at enrollment)
Baseline (single time point at enrollment)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Qinghua Yu, DiproBio (Shanghai) Co., Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de abril de 2026

Finalización primaria (Estimado)

1 de marzo de 2030

Finalización del estudio (Estimado)

1 de marzo de 2031

Fechas de registro del estudio

Enviado por primera vez

10 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de julio de 2026

Publicado por primera vez (Actual)

15 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SECCR2025-158-01

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Fecal Gut Microbiota

3
Suscribir