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| Name | Class |
|---|---|
| Merieux NutriSciences (China) | UNKNOWN |
| BioFortis | OTHER |
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The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Novel infant formula |
|
| Control | Active Comparator | Standard infant formula |
|
| Reference | No Intervention | Breastfeeding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel infant formula | Other | Infants are fed with the novel infant formula from the date of enrollment to the age of 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily body weight gain between V1 and V3 | From baseline to the age of 6 months | |
| Fecal total pathogens load | From baseline to the age of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secretory IgA, calprotectin and antitrypsin A1 in feces at V1, V2 and V3 | From baseline to the age of 3 months and the age of 6 months | |
| sIgA in saliva at V1, V2 and V3 | From baseline to the age of 3 months and the age of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The breast milk composition | At baseline only |
Inclusion Criteria:
Exclusion Criteria:
Conditions requiring infant feedings other than those specified in the protocol.
Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:
Currently participating or having participated in another interventional clinical trial since birth.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foshan Maternal and Child Health Hospital | Foshan | China | ||||
| Guangzhou Women and Children's Medical Center |
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| Standard infant formula | Other | Infants are fed with the standard infant formula from the date of enrollment to the age of 6 months. |
|
| Incidence of allergic disease reported by caregivers | From baseline to the age of 3 months and the age of 6 months |
| Incidence of infectious disease reported by caregivers | from baseline to the age of 3 months and the age of 6 months |
| Incidence of medications use reported by caregivers | From baseline to the age of 3 months and the age of 6 months |
| Additional anthropometric measures (body length and head circumference) | From baseline to the age of 3 months and the age of 6 months |
| GI symptoms and GI-related behaviors assessed via Infant Gastrointestinal Symptom Questionnaire (IGSQ) | From baseline to the age of 3 months and the age of 6 months |
| Stooling patterns assessed via Amsterdam Infant Stool Scale (AISS) | From baseline to the age of 3 months and the age of 6 months |
| Overall composition of the fecal microbiota | From baseline to the age of 3 months and the age of 6 months |
| Fecal metabolome profiles | From baseline to the age of 3 months and the age of 6 months |
| Guangzhou |
| China |
| Shenzhen Hospital of Southern Medical University | Shenzhen | China |
| Shenzhen Integrated Traditional Chinese and Western Medicine Hospital | Shenzhen | China |
| Zhongshan Boai Hospital | Zhongshan | China |