Nutrition, Microbiome and Bone Health During Early Life Related to Health (Bamboo)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other

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

• Study Type: Observational
• Enrollment (Actual): 2760

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Tianjin Women and Children Health Center，

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 6 months (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Group 1: 690 healthy infants and their mother followed from birth to 12 months Group 2: 690 healthy infants and their mother followed from 6 months to 3 years of age

Description

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1; Group 1: 690 healthy infants and their mother followed from birth to 12 months
Group 2; Group 2: 690 healthy infants and their mother followed from 6 months to 3 years of age

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Veeva Systems; SAS Institute; BGI-research; Cognizant Technology Solutions AG; Tianjin Women and Children's Health Center
• Investigators: Principal Investigator: Gongshu Liu, Dr., Tianjin Women and Children Health Center

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Actual): September 8, 2025
• Study Completion (Actual): September 8, 2025

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20.27.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No