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| Name | Class |
|---|---|
| Nutricia Early Life Nutrition (Shanghai) Co., Ltd | UNKNOWN |
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This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.
Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.
Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.
Safety, growth and tolerance parameters will be followed and collected throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New infant formula with synbiotics | Experimental | pHP infant formula with synbiotics (test product) |
|
| Standard infant formula with prebiotics | Active Comparator | Standard (commercial) infant formula with prebiotics (control product) |
|
| human milk | No Intervention | Full breastfeeding for at least 17 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New infant formula with synbiotics | Dietary Supplement | Infants are fed with synbiotics formula for 17 weeks from the date of enrollment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain per day from baseline (g/day) | at the age of 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant. | at the age of 17 weeks | |
| Increment per day from baseline on length (mm/day) | at the age of 17 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- The mothers of infants:
who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;
- Parents/Legally acceptable representatives/Caregivers of infants:
who are incapable to comply with study protocol
- Infants:
who have to be fed with a special diet other than standard cow's milk based infant formula;
known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
known or suspected to have an allergic condition towards cow's milk, soy or fish;
with any history of, or current participation in any other study involving investigational or marketed products.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University 3rd Hospital | Beijing | Beijing Municipality | China | |||
| Guangzhou women and Children's Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39915586 | Derived | Wang Y, Wopereis H, Kakourou A, Liu M, Wu J, Li Z, Zhang L, Tan M, Low JSY, Liu M, Roeselers G, Knol J, Cai W. Restoration of gut microbiota with a specific synbiotic-containing infant formula in healthy Chinese infants born by cesarean section. Eur J Clin Nutr. 2025 Jun;79(6):567-575. doi: 10.1038/s41430-025-01571-8. Epub 2025 Feb 6. |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Intervention group: New infant formula with synbiotics; Control group: Standard infant formula with prebiotics
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| Standard infant formula with prebiotics | Dietary Supplement | Infants are fed with prebiotics formula for 17 weeks from the date of enrollment. |
|
| Increment per day from baseline on head circumference (mm/day) | at the age of 17 weeks |
| Increment per day from baseline on mid-upper arm circumference (mm/day) | at the age of 17 weeks |
| Z-scores of anthropometric parameters from baseline on weight | from baseline until the age of 17 weeks |
| Z-scores of anthropometric parameters from baseline on length | from baseline until the age of 17 weeks |
| Z-scores of anthropometric parameters from baseline on head circumference | from baseline until the age of 17 weeks |
| Z-scores of anthropometric parameters from baseline on mid-upper arm circumference | from baseline until the age of 17 weeks |
| Effect on incidence, frequency and severity of (serious) adverse events | from baseline until the age of 17 weeks |
| Parent-reported occurrence of diarrhea | from baseline until the age of 17 weeks |
| Parent-reported severity of diarrhea | from baseline until the age of 17 weeks |
| Parent-reported occurrence of constipation | from baseline until the age of 17 weeks |
| Parent-reported severity of constipation | from baseline until the age of 17 weeks |
| Guangzhou |
| Guangdong |
| 510623 |
| China |
| Guangdong Province Maternal and Children Hospital | Guangzhou | Guangdong | China |
| Wuxi Poeple's Hospital | Wuxi | Jiangsu | China |
| Shanghai Public Health Clinical Research Center | Shanghai | Shanghai Municipality | China |
| Xin Hua Hospital | Shanghai | Shanghai Municipality | China |
| D019936 |
| Probiotics |
| D019602 | Food and Beverages |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |