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The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starter infant formula without HMO | Placebo Comparator | Volumes of feed depend on age, weight and appetite. |
|
| Starter infant formula with 2 HMOs | Active Comparator | Volumes of feeds depend on age, weight and appetite |
|
| Breasfed reference group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth | child growth (body weight) from enrollment to 4 months of age | 4 months of life |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | 6 and 12 months of age | |
| Digestive tolerance (stool charecteristics, bowel movements,behavior patterns) | Parents are asked to complete a diary on digistive tolerance of their child | every month during 6 months |
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Inclusion Criteria:
babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed
• BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni CORSELLO | Dipartimento Materno Infantile, Palermo | Principal Investigator |
| Philippe ALLIET | Kinderartsenpraktijk, Hasselt, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinderartsenpraktijk | Hasselt | 3500 | Belgium | |||
| Dipartimento Materno Infantile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37438187 | Derived | Tarrant I, Finlay BB. Human milk oligosaccharides: potential therapeutic aids for allergic diseases. Trends Immunol. 2023 Aug;44(8):644-661. doi: 10.1016/j.it.2023.06.003. Epub 2023 Jul 11. | |
| 34576834 | Derived | Dogra SK, Martin FP, Donnicola D, Julita M, Berger B, Sprenger N. Human Milk Oligosaccharide-Stimulated Bifidobacterium Species Contribute to Prevent Later Respiratory Tract Infections. Microorganisms. 2021 Sep 12;9(9):1939. doi: 10.3390/microorganisms9091939. |
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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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| Product compliance (quantity of formula in ml consumed on the 3 days before visit) | Parents are asked to complete a diary on the product compliance | every month for 6 months |
| Morbidity | ongoing for 1 year |
| Stool microbiota | 3 and 12 months of age |
| Gene expression | 3 and 12 months of age |
| Palermo |
| 90127 |
| Italy |
| 32184252 | Derived | Berger B, Porta N, Foata F, Grathwohl D, Delley M, Moine D, Charpagne A, Siegwald L, Descombes P, Alliet P, Puccio G, Steenhout P, Mercenier A, Sprenger N. Linking Human Milk Oligosaccharides, Infant Fecal Community Types, and Later Risk To Require Antibiotics. mBio. 2020 Mar 17;11(2):e03196-19. doi: 10.1128/mBio.03196-19. |
| 28107288 | Derived | Puccio G, Alliet P, Cajozzo C, Janssens E, Corsello G, Sprenger N, Wernimont S, Egli D, Gosoniu L, Steenhout P. Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):624-631. doi: 10.1097/MPG.0000000000001520. |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |