Nutrition, Microbiome and Bone Health During Early Life Related to Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-03

Study Completion Date

2025-09-08

Brief Summary

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The aim of the study is to establish the longitudinal microbiome and bone trajectories from birth to 3 years, and to evaluate the influence of nutrition on these trajectories.

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Detailed Description

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The main objective of the study is to understand the influence of nutrition and dietary patterns on microbiome and bone trajectories during early life. Specific research objectives are:

* Establish the reference trajectories of gut microbiome maturation index and bone development in healthy Chinese children aged 0-3years
* Assess the impact of early life nutrition on gut microbiome trajectory
* Investigate the influence of microbiome, early life parameters and nutritional parameters on bone health

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Group 1: 690 healthy infants and their mother followed from birth to 12 months

Intervention Type OTHER

No intervention

Group 2

Group 2: 690 healthy infants and their mother followed from 6 months to 3 years of age

Intervention Type OTHER

No intervention

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the subject's parents/LAR have been informed of all pertinent aspects of the study.
2. Subject's parent(s)/LAR is of legal age of consent, is willing and able to fulfill the requirements of the study protocol.
3. For group 1, healthy infants aged ≤ 10 days after birth (date of birth = Day 0).

For group 2, healthy infants with maximum age of 6 months
4. Full-term gestational birth (≥ 37 and ≤ 42 weeks).
5. Subject's parent(s)/LAR is able to be contacted directly by telephone throughout the study.
6. Both parents registered have a fixed work and / or residence within their jurisdiction.

Exclusion Criteria

1. Complicated pregnancy (e.g., preeclampsia, gestational diabetes, bowel disease) as assessed by medical interview/ medical record when available
2. Infant's parents/LAR not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
3. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start.

Minimum Eligible Age

0 Days

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No