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CompletedNCT05160675BambooUpdated Nov 28, 2025

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

An observational study in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in China. Open to participants aged 0 Days to 6 Months. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Société des Produits Nestlé (SPN) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,760
Ages
0 Days to 6 Months
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 6 Months
Sexes eligible
All
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,760 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. gut microbiome

    microbiome maturation index derived from microbial composition, bacteria function, metabolites

    Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years

  2. dietary factors

    derived from infant questionnaires

    Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years

  3. 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

    Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years

  4. bone development

    bone tibia speed of sounds (SOS) (meter / second) using ultrasound

    Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years

  5. bone health

    Bone tibia length using ruler (cm)

    Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years

  6. 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

    Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years

Secondary outcomes

  1. Gut microbiome

    microbiome maturation index derived from microbial composition, bacteria function, metabolites

    Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years

  2. Urinary markers of bone metabolism

    urinary resorption biomarkers which are Pyridinolin and Deoxypiridinolin Crosslinks by ELISA

    Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years

  3. breast milk composition

    breast milk composition, macro and micronutrients (e.g. protein, mineral, etc.)

    Time frame: Group 1: 0-3 months

07

Study locations

1 site
  • Tianjin Women and Children Health Center,
    Tianjin, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05160675
Lead sponsor
Société des Produits Nestlé (SPN)
Collaborators
Tianjin Women and Children's Health Center, BGI-research, Cognizant Technology Solutions AG, SAS Institute, Veeva Systems
Responsible party
Sponsor
First posted
Dec 16, 2021
Start date
Sep 3, 2021
Primary completion
Sep 8, 2025
Completion
Sep 8, 2025
Last update
Nov 28, 2025

Study contacts

Gongshu Liu, Dr.
principal investigator · Tianjin Women and Children Health Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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