Clinical trial NCT05160675: Nutrition, Microbiome and Bone Health During Early Life Related to Health
Official title: Nutrition, Microbiome and Bone Health During Early Life Related to Health
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Tianjin Women and Children's Health Center
name: BGI-research
name: Cognizant Technology Solutions AG
name: SAS Institute
name: Veeva Systems
First posted: 2021-12-16
Enrollment: 2760
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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.

Primary outcomes:
measure: gut microbiome
timeFrame: Group 1: 0-1 year, Group 2: 0.5-3 years
measure: dietary factors
timeFrame: Group 1: 0-1 year, Group 2: 0.5-3 years
measure: dietary factors
timeFrame: Group 1: 0-1 year, Group 2: 0.5-3 years
measure: bone development
timeFrame: Group 1: 0-1 year, Group 2: 0.5-3 years
measure: bone health
timeFrame: Group 1: 0-1 year, Group 2: 0.5-3 years
measure: dietary intakes and health outcomes
timeFrame: Group 1: 0-1 year, Group 2: 0.5-3 years
Secondary outcomes:
measure: Gut microbiome
timeFrame: Group 1: 0-1 year, Group 2: 0.5-3 years
measure: Urinary markers of bone metabolism
timeFrame: Group 1: 0-1 year, Group 2: 0.5-3 years
measure: breast milk composition
timeFrame: Group 1: 0-3 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Women and Children Health Center，
Study officials:
affiliation: Tianjin Women and Children Health Center
name: Gongshu Liu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: