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

NCT05160675 | Completed

• 1 other identifier: 20.27.NRC
• Study Type: observational
• Target: 2,760
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Gut microbiome

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

• Urinary markers of bone metabolism

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

• breast milk composition

  Group 1: 0-3 months

Study Arms (2)

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

Eligibility Criteria

• Age: 0 Days - 6 Months
• Sex: all
• Age Groups: Child (0-17)
• 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

You may not qualify if:

• 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.
• Subject's parent(s)/LAR is of legal age of consent, is willing and able to fulfill the requirements of the study protocol.
• 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
• Full-term gestational birth (≥ 37 and ≤ 42 weeks).
• Subject's parent(s)/LAR is able to be contacted directly by telephone throughout the study.
• Both parents registered have a fixed work and / or residence within their jurisdiction.
• Complicated pregnancy (e.g., preeclampsia, gestational diabetes, bowel disease) as assessed by medical interview/ medical record when available
• Infant's parents/LAR not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
• Currently participating or having participated in another clinical trial within 4 weeks prior to trial start.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Tianjin Women and Children's Health Center: collaborator
• BGI-research: collaborator
• Cognizant Technology Solutions AG: collaborator
• SAS Institute: collaborator
• Veeva Systems: collaborator

Study Sites (1)

Tianjin Women and Children Health Center，

Tianjin, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal, urine sample of the infants, and breastmilk from the mothers

Study Officials

• Gongshu Liu, Dr.

  Tianjin Women and Children Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 16, 2021
• Study Start: September 3, 2021
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)