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

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT05160675
• Lead Sponsor: Société des Produits Nestlé (SPN)

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

Study Timeline

• Study Start: 2021-09-03
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2760

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dietary factors	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	Group 1: 0-1 year, Group 2: 0.5-3 years	microbiome maturation index derived from microbial composition, bacteria function, metabolites
bone development	Group 1: 0-1 year, Group 2: 0.5-3 years	bone tibia speed of sounds (SOS) (meter / second) using ultrasound
bone health	Group 1: 0-1 year, Group 2: 0.5-3 years	Bone tibia length using ruler (cm)
dietary intakes and health outcomes	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 Outcome Measures

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

Trial Locations

Locations (1)

Tianjin Women and Children Health Center，; 🇨🇳 Tianjin, China