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Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants compare with an otherwise identical widely used commercially available milk based infant formula and/or breast feed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Materna infant formula 1 | Placebo Comparator | milk based infant formula powder |
|
| Materna infant formula 2 | Experimental | Probiotic supplemented infant formula |
|
| Materna infant formula 3 | Experimental | Prebiotic supplemented infant formula |
|
| Materna infant formula 4 | Experimental | Prebiotic+ Probiotic supplemented infant formula |
|
| Human milk | Other | Human Milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| weight gain | 1 to 120 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric | 1-120 days of age | |
| GI tolerance | 1-120 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| Influence on the microbial content of the stool | Stool were collected to analyze the microbial content of certain bacteria upon enrollment and at the age of 4, 16. and 36 w Stool were collected and delivery to the lab in coolers within 12 h | 3 - 4 times: 1-16 d, 4 w 16 w and 36 w |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nehama Linder, M.D. Ph.D | Neonatology department, Rabin Medical center, Petach Tikva. Israel | Principal Investigator |
| Raanan Shamir, M.D. Ph.D. | Institute of Gastroenterology Nutrition and Liver Diseases Schneider children medical center, Petach Tikva. | Principal Investigator |
| Kobi Shiff, M.D. | Neonatology department, Laniado Hospital- Sanz Medical Center, Netanya, Israel. | Principal Investigator |
| Zvi Weizman, M.D. Ph.D | Department of Pediatrics, Soroka University Medical Center, Beer-Sheva, Israel. | Principal Investigator |
| Uri Rubenstein, M.D | clinic, 1 Yehuda Perach St., Natanya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatology department, Laniado Hospital- Sanz Medical Center, . | Netanya | Israel |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |