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To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk
Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo comparator (Control) | Placebo Comparator | Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite. |
|
| Experimental Formula (Test) | Experimental | Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite. |
|
| Breastfed reference group | No Intervention | Breastfed reference group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula (CF) | Dietary Supplement | Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | Growth (weight gain velocity) | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | Other growth outcomes will be compared to the World Health Organization 2006 Growth Standards and by treatment group | Every month up to 6 months of age |
| Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Alliet | Kinderartsen Huis 5 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Stedelijk Ziekenhuis Aalst | Aalst | Belgium | ||||
| UZ Brussel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35193609 | Derived | Alliet P, Vandenplas Y, Roggero P, Jespers SNJ, Peeters S, Stalens JP, Kortman GAM, Amico M, Berger B, Sprenger N, Cercamondi CI, Corsello G. Safety and efficacy of a probiotic-containing infant formula supplemented with 2'-fucosyllactose: a double-blind randomized controlled trial. Nutr J. 2022 Feb 22;21(1):11. doi: 10.1186/s12937-022-00764-2. |
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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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| Infant Formula (EF) | Dietary Supplement | Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days. |
|
Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency) |
| Every month up to 6 months of age |
| GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake) | GI tolerance (3-day GI symptom and behavior diary - including GI symptoms (frequency and amount of spitting-up/vomiting, and frequency of flatulence), GI-related behaviors (duration of crying and fussiness, sleeping, and the frequency of excessive crying episodes), and milk intake) | Every month up to 6 months of age |
| Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR) | Fecal microbiota composition, diversity, and abundance | Every month up to 4 months of age |
| Fecal markers (pH, fecal organic acids, and protein markers of gut health) | Fecal markers (pH, fecal organic acids, and protein markers of gut health) | Every month up to 4 months of age |
| Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing) | Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing) | Up to 3 months of age |
| Adverse events / Morbidity | Adverse events / Morbidity | 180 days |
| Brussels |
| Belgium |
| Kinderartsen Huis5 | Hasselt | 3500 | Belgium |
| Clinique Ste Elisabeth | Namur | Belgium |
| CHwapi | Tournai | Belgium |
| Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico | Milan | Italy |
| AOUP "Paolo Giaccone" | Palermo | Italy |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |