Nutrition, Microbiome and Bone Health During Early Life Related to Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 2760
- Locations
- 1
- Primary Endpoint
- dietary factors
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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
Investigators
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:
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
dietary factors
Time Frame: Group 1: 0-1 year, Group 2: 0.5-3 years
derived from food diaries of the types of complementary feeding, the food consumption, the nutrient intakes, the food source of nutrients, the dietary patterns
gut microbiome
Time Frame: Group 1: 0-1 year, Group 2: 0.5-3 years
microbiome maturation index derived from microbial composition, bacteria function, metabolites
bone development
Time Frame: Group 1: 0-1 year, Group 2: 0.5-3 years
bone tibia speed of sounds (SOS) (meter / second) using ultrasound
bone health
Time Frame: Group 1: 0-1 year, Group 2: 0.5-3 years
Bone tibia length using ruler (cm)
dietary intakes and health outcomes
Time Frame: 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
Secondary Outcomes
- Urinary markers of bone metabolism(Group 1: 0-1 year, Group 2: 0.5-3 years)
- Gut microbiome(Group 1: 0-1 year, Group 2: 0.5-3 years)
- breast milk composition(Group 1: 0-3 months)