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| Name | Class |
|---|---|
| Edanz Inc | UNKNOWN |
| Cyanth (Wuxi) Health Technology Co. Ltd. | UNKNOWN |
| Affiliated Hospital of Jiangnan University | OTHER |
| Guangzhou Trials Medical |
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The aim of the study is to compare the effects of conventional Ultra High Temperature (UHT) milk containing both A1 and A2 type β-caseins (CON) with a2 UHT Milk containing A2 type β-casein only (A1PF) on inflammation, tolerance, and GI symptoms in pregnant women as well as infants' birth outcomes from 12 weeks' gestation up to 40 days post-birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a2 UHT Milk | Active Comparator | containing A2 type β-casein only (A1PF) |
|
| Conventional UHT milk | Placebo Comparator | containing both A1 and A2 type β-caseins (CON) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a2 UHT milk | Other | Pregnant women in this arm will drink a2 UHT Milk twice a day, 200ml each time, until study completion. Their infants will be fed with the mother's breastmilk exclusively. |
| Measure | Description | Time Frame |
|---|---|---|
| GI tolerance | GI tolerance via the GSRS questionnaire | Visit 1 (baseline, 12 weeks' gestation) |
| GI tolerance | GI tolerance via the GSRS questionnaire | Visit 2 (24 weeks' gestation) |
| GI tolerance | GI tolerance via the GSRS questionnaire | Visit 3 (36 weeks' gestation) |
| GI tolerance | GI tolerance via the GSRS questionnaire | Visit 4 (40 days after delivery) |
| IL-4 | Blood IL-4 levels | Visit 1 (baseline, 12 weeks' gestation) |
| IL-4 | Blood IL-4 levels | Visit 2 (24 weeks' gestation) |
| IL-4 | Blood IL-4 levels | Visit 3 (36 weeks' gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy complications | Incidence of pregnancy complications | Visit 1 (baseline, 12 weeks' gestation) |
| pregnancy complications | Incidence of pregnancy complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foshan Maternity & Child Healthcare Hospital | Foshan | Guangdong | 528000 | China | ||
| Panyu Maternal and Child Care Service Centre of Guangzhou |
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| UNKNOWN |
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| Conventional UHT Milk | Other | Pregnant women in this arm will drink conventional UHT Milk twice a day, 200ml each time, until study completion. Their infants will be fed with the mother's breastmilk exclusively. |
|
| Visit 2 (24 weeks' gestation) |
| pregnancy complications | Incidence of pregnancy complications | Visit 3 (36 weeks' gestation) |
| pregnancy complications | Incidence of pregnancy complications | Visit 4 (40 days after delivery) |
| GSH levels | Blood GSH levels | Visit 1 (baseline, 12 weeks' gestation) |
| GSH levels | Blood GSH levels | Visit 2 (24 weeks' gestation) |
| GSH levels | Blood GSH levels | Visit 3 (36 weeks' gestation) |
| IgG levels | Blood IgG levels | Visit 1 (baseline, 12 weeks' gestation) |
| IgG levels | Blood IgG levels | Visit 2 (24 weeks' gestation) |
| IgG levels | Blood IgG levels | Visit 3 (36 weeks' gestation) |
| IL-1 levels | Blood IL-1 levels | Visit 1 (baseline, 12 weeks' gestation) |
| IL-1 levels | Blood IL-1 levels | Visit 2 (24 weeks' gestation) |
| IL-1 levels | Blood IL-1 levels | Visit 3 (36 weeks' gestation) |
| hsCRP | Blood hsCRP levels | Visit 1 (baseline, 12 weeks' gestation) |
| hsCRP | Blood hsCRP levels | Visit 2 (24 weeks' gestation) |
| hsCRP | Blood hsCRP levels | Visit 3 (36 weeks' gestation) |
| TNF-α | Blood TNF-α levels | Visit 1 (baseline, 12 weeks' gestation) |
| TNF-α | Blood TNF-α levels | Visit 2 (24 weeks' gestation) |
| TNF-α | Blood TNF-α levels | Visit 3 (36 weeks' gestation) |
| Vitamin D | Blood vitamin D levels | Visit 1 (baseline, 12 weeks' gestation) |
| Vitamin D | Blood vitamin D levels | Visit 2 (24 weeks' gestation) |
| Vitamin D | Blood vitamin D levels | Visit 3 (36 weeks' gestation) |
| Infant birth outcomes | Infant birth outcomes, including anthropometric measurements (weight, length, head circumference, z-scores, Apgar score) | Visit 4 (40 days after delivery) |
| Breastmilk composition | Breastmilk composition analyssis including metal ion testing, proteins, fats and HMOs | Visit 4 (40 days after delivery) |
| infant GI signs and symptoms | infant GI signs and symptoms assessed by IGSQ questionnaire | Visit 4 (40 days after delivery) |
| Adverse events | Record adverse events | Visit 1 (baseline, 12 weeks' gestation) |
| Adverse events | Record adverse events | Visit 2 (24 weeks' gestation) |
| Adverse events | Record adverse events | Visit 3 (36 weeks' gestation) |
| Adverse events | Record adverse events | Visit 4 (40 days after delivery) |
| Guangzhou |
| Guangdong |
| 511400 |
| China |
| Wuxi Maternal and Child Health Hospital | Wuxi | Jiangsu | 214002 | China |
| Affiliated hospital of Jiangnan University | Wuxi | Jiangsu | 214122 | China |
| Xuzhou Maternal and Child Health Hospital | Xuzhou | Jiangsu | 221009 | China |
| First People's Hospital of Chengdu | Chengdu | Sichuan | 610041 | China |