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| Name | Class |
|---|---|
| Tianjin Women and Children's Health Center | OTHER |
| BGI-research | OTHER |
| Cognizant Technology Solutions AG | UNKNOWN |
| SAS Institute |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| gut microbiome | microbiome maturation index derived from microbial composition, bacteria function, metabolites | Group 1: 0-1 year, Group 2: 0.5-3 years |
| dietary factors | derived from infant questionnaires | 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 | Group 1: 0-1 year, Group 2: 0.5-3 years |
| bone development | bone tibia speed of sounds (SOS) (meter / second) using ultrasound | Group 1: 0-1 year, Group 2: 0.5-3 years |
| bone health | Bone tibia length using ruler (cm) | 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 | Group 1: 0-1 year, Group 2: 0.5-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome | microbiome maturation index derived from microbial composition, bacteria function, metabolites | 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 |
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Inclusion Criteria:
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:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Gongshu Liu, Dr. | Tianjin Women and Children Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Women and Children Health Center, | Tianjin | China |
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| INDUSTRY |
| Veeva Systems | INDUSTRY |
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Fecal, urine sample of the infants, and breastmilk from the mothers
| 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.) | Group 1: 0-3 months |