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| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
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The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.
The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well.
As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infant formula containing five HMOs | Experimental |
| |
| infant formula | No Intervention | ||
| breast milk group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human milk oligosaccharides | Dietary Supplement | mixture of five different human milk oligosaccharides |
|
| Measure | Description | Time Frame |
|---|---|---|
| assessment of body weight (in grams) of term infants | growth, assessed by body weight gain, of term infants from enrollment to 4 month of life | 4 month |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of body length (in centimeter) of term infants | growth, assessed as body length, of term infants from enrollment to 4 month of life | 4 month |
| assessment of head circumference (in centimeter) of term infants |
| Measure | Description | Time Frame |
|---|---|---|
| digestive tolerance | stool frequency and consistency | 4 month |
| influence of digestion | digestive tolerance parameters ( e.g. rigurgitation, flatulence) will be assessed |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Jochum, Dr. med. | Universitaetsmedizin Berlin, Charité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facharzt für Kinder und Jugendmedizin | Mannheim | 68161 | Germany | |||
| Klinikum Südstadt Rostock |
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growth, assessed as head circumference, of term infants from enrollment to 4month of life
| 4 month |
| 4 month |
| influence on behaviour | behavior patterns (e.g.fussiness, cramps, awakings at night) will be assessed | 4 month |
| product compliance | intake of infant formula in ml | 4 month |
| morbidity | observation of illness | 4 month |
| stool microbiota | analysis of the fecal microbiota | 4 month |
| HMO composition in breast milk | analysis of HMO composition in mothers breastmilk in the breast-fed arm | 4 month |
| Rostock |
| 18059 |
| Germany |
| ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini | Brescia | 25123 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Hospital HM Puerta del Sur | Madrid | 28015 | Spain |
| Hospital HM Monteprincipe | Madrid | 28660 | Spain |
| Hospital HM Nuevo Belen | Madrid | 28938 | Spain |
| Hospital Universitario Sant Joan de Reus | Reus | 43204 | Spain |
| Hospital Joan XXII of Tarragona | Tarragona | 43005 | Spain |