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

Healthy Clinical Trial

— Bamboo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05160675
• Other study ID #: 20.27.NRC
• Status: Active, not recruiting
• Start date: September 3, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2760
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Gender: All
• Age group: 0 Days to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
China	Tianjin Women and Children Health Center,	Tianjin

Sponsors (6)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	BGI-research, Cognizant Technology Solutions AG, SAS Institute, Tianjin Women and Children's Health Center, Veeva Systems

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut microbiome	microbiome maturation index derived from microbial composition, bacteria function, metabolites	Group 1: 0-1 year, Group 2: 0.5-3 years
Primary	dietary factors	derived from infant questionnaires	Group 1: 0-1 year, Group 2: 0.5-3 years
Primary	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
Primary	bone development	bone tibia speed of sounds (SOS) (meter / second) using ultrasound	Group 1: 0-1 year, Group 2: 0.5-3 years
Primary	bone health	Bone tibia length using ruler (cm)	Group 1: 0-1 year, Group 2: 0.5-3 years
Primary	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	Gut microbiome	microbiome maturation index derived from microbial composition, bacteria function, metabolites	Group 1: 0-1 year, Group 2: 0.5-3 years
Secondary	Urinary markers of bone metabolism	urinary resorption biomarkers which are Pyridinolin and Deoxypiridinolin Crosslinks by ELISA	Group 1: 0-1 year, Group 2: 0.5-3 years
Secondary	breast milk composition	breast milk composition, macro and micronutrients (e.g. protein, mineral, etc.)	Group 1: 0-3 months