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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05160675

Acronym

Bamboo

Enrollment

2760

Registered

2021-12-16

Start date

2021-09-03

Completion date

2025-09-08

Last updated

2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 6 Months

Inclusion criteria

* It is important to carefully consider whether a subject is suitable for enrollment into this observational study. Fulfillment of the inclusion and

Exclusion criteria

for each subject will be documented by a qualified member of the investigative staff before any subject is enrolled. Healthy infants who fulfill all the following inclusion criteria will be included: 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.

Design outcomes

Primary

Measure	Time frame	Description
dietary intakes and health outcomes	Group 1: 0-1 year, Group 2: 0.5-3 years	derived from infant questionnaires and their food diaries of the types of complementary feeding, the food consumption, the nutrient intakes, the food source of nutrients, the dietary patterns
dietary factors	Group 1: 0-1 year, Group 2: 0.5-3 years	derived from infant questionnaires
bone development	Group 1: 0-1 year, Group 2: 0.5-3 years	bone tibia speed of sounds (SOS) (meter / second) using ultrasound
bone health	Group 1: 0-1 year, Group 2: 0.5-3 years	Bone tibia length using ruler (cm)
gut microbiome	Group 1: 0-1 year, Group 2: 0.5-3 years	microbiome maturation index derived from microbial composition, bacteria function, metabolites

Secondary

Measure	Time frame	Description
Urinary markers of bone metabolism	Group 1: 0-1 year, Group 2: 0.5-3 years	urinary resorption biomarkers which are Pyridinolin and Deoxypiridinolin Crosslinks by ELISA
breast milk composition	Group 1: 0-3 months	breast milk composition, macro and micronutrients (e.g. protein, mineral, etc.)
Gut microbiome	Group 1: 0-1 year, Group 2: 0.5-3 years	microbiome maturation index derived from microbial composition, bacteria function, metabolites

Countries

China

Outcome results