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Completed

NCT Number: NCT05160675

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

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.

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Key information

Conditions

Age range

0 day–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Women and Children Health Center,

Tianjin, China

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. dietary factors

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

    derived from infant questionnaires

  3. 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

  4. 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

  5. bone health

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

    Bone tibia length using ruler (cm)

  6. 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

  1. 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

  2. Urinary markers of bone metabolism

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

    urinary resorption biomarkers which are Pyridinolin and Deoxypiridinolin Crosslinks by ELISA

  3. breast milk composition

    Time frame: Group 1: 0-3 months

    breast milk composition, macro and micronutrients (e.g. protein, mineral, etc.)

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • BGI-research
  • Cognizant Technology Solutions AG
  • SAS Institute
  • Tianjin Women and Children's Health Center
  • Veeva Systems

Registry information

Acronym: Bamboo

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2021
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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