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The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IF (Infant formula) | No Intervention | ||
| IF with L. paracasei strain F19 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus paracasei paracasei strain F19 | Other | Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth (body weight, length, head circumference) | From 28 days to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hania Szajewska, MD | Samodzielny Publiczny Dziecięcy Szpital, Warsaw | Principal Investigator |
| Jacek Witwicki, MD | Samodzielny Publiczny Dziecięcy Szpital Kliniczny, Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samodzielny Publiczny Dziecięcy Szpital Kliniczny | Warsaw | 01-184 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36803508 | Derived | Sjodin KS, Sjodin A, Ruszczynski M, Kristensen MB, Hernell O, Szajewska H, West CE. Targeting the gut-lung axis by synbiotic feeding to infants in a randomized controlled trial. BMC Biol. 2023 Feb 20;21(1):38. doi: 10.1186/s12915-023-01531-3. |
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| ID | Term |
|---|---|
| C092354 | 11-fluoro-19-nor-dihydro-testosterone |
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