HealthyBambooNCT05160675
Nutrition, Microbiome and Bone Health During Early Life Related to Health
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 0 days to 6 months
- Conditions the study is for
- Healthy
- How many people
- 2,760 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2021to 8 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 6 months
- All sexes
- Child
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
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1: 690 healthy infants and their mother followed from birth to 12 months | |
| Group 2 | Group 2: 690 healthy infants and their mother followed from 6 months to 3 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiome
microbiome maturation index derived from microbial composition, bacteria function, metabolites
Measured: Group 1: 0-1 year, Group 2: 0.5-3 years
dietary factors
derived from infant questionnaires
Measured: Group 1: 0-1 year, Group 2: 0.5-3 years
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
Measured: Group 1: 0-1 year, Group 2: 0.5-3 years
bone development
bone tibia speed of sounds (SOS) (meter / second) using ultrasound
Measured: Group 1: 0-1 year, Group 2: 0.5-3 years
bone health
Bone tibia length using ruler (cm)
Measured: Group 1: 0-1 year, Group 2: 0.5-3 years
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
Measured: Group 1: 0-1 year, Group 2: 0.5-3 years
Secondary outcomes (3)
Gut microbiome
microbiome maturation index derived from microbial composition, bacteria function, metabolites
Measured: Group 1: 0-1 year, Group 2: 0.5-3 years
Urinary markers of bone metabolism
urinary resorption biomarkers which are Pyridinolin and Deoxypiridinolin Crosslinks by ELISA
Measured: Group 1: 0-1 year, Group 2: 0.5-3 years
breast milk composition
breast milk composition, macro and micronutrients (e.g. protein, mineral, etc.)
Measured: Group 1: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start3 Sep 2021
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Women and Children's Health Center, BGI-research, Cognizant Technology Solutions AG, SAS Institute, Veeva Systems
- Responsible party
- Sponsor
- Investigators
- Gongshu Liu, Dr., Principal investigator, Tianjin Women and Children Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160675
- Sponsor's protocol ID
- 20.27.NRC
- Acronym
- Bamboo
- Status last verified
- Nov 2025
- First submitted
- 13 Oct 2021
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition, Microbiome and Bone Health During Early Life Related to Health
- ClinicalTrials.gov ID
- NCT05160675
- Acronym / sponsor ID
- Bamboo / 20.27.NRC
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,760 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Women and Children's Health Center, BGI-research, Cognizant Technology Solutions AG, SAS Institute, Veeva Systems
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Group 1: 690 healthy infants and their mother followed from birth to 12 months |
| Group 2 | – | –Group 2: 690 healthy infants and their mother followed from 6 months to 3 years of age |
Who may qualify
- Ages
- 0 days to 6 months
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (9 listed)
- 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.
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Group 1, Group 2 |
Primary outcome
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
dietary factors
Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years
derived from infant questionnaires
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
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
3 secondary outcomes
Gut microbiome
Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years
Urinary markers of bone metabolism
Time frame: Group 1: 0-1 year, Group 2: 0.5-3 years
breast milk composition
Time frame: Group 1: 0-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gongshu Liu, Dr. principal investigator
Tianjin Women and Children Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiome (time frame: Group 1: 0-1 year, Group 2: 0.5-3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.