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The aim of this study was to assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based infant formula (GMF) compared to cow's milk-based infant formula (CMF) during a 24 week intervention.
Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this double-blind, randomized controlled trial, gastrointestinal comfort in infants fed goat milk-based infant formula (GMF) or cow's milk-based infant formula (CMF) was studied.
Fifty-six healthy infants aged 3-12 months were followed for 24 weeks. Stool consistency, regurgitation frequency and crying duration were measured weekly using an adapted version of the Cow's Milk-related Symptom Score (CoMiSS®) where only the items for these scores were used. Blood hemoglobin levels were measured at the start and at the end of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goat milk-based infant formula | Experimental | Experimental group receives goat milk-based formula for 24 weeks |
|
| Cow's milk-based infant formula | Active Comparator | Control group receives cow's milk-based formula for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goat milk-based infant formula | Dietary Supplement | Goat milk-based infant formula fed at age appropriate quantities for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms | Stool consistency, regurgitation frequency and crying duration as measured by an adapted Cow's Milk-related Symptom Score®, where a higher score indicates more severe symptoms. | 24 weeks, measured weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Blood hemoglobin levels | Blood hemoglobin levels before and after intervention | 24 weeks, measured at start and end |
| WHO z-score of weight-for-age | Weight measured to the nearest 5.0 grams with clothes and diaper removed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugo da Costa Ribeiro, Dr. | Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daycare center | Salvador | Estado de Bahia | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39567910 | Derived | Maximino P, van Lee L, Meijer-Krommenhoek YN, van der Zee L, da Costa Ribeiro Junior H. Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow's milk-based formula: a double-blind, randomized, controlled trial. BMC Pediatr. 2024 Nov 20;24(1):753. doi: 10.1186/s12887-024-05214-y. |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D007228 | Infant Nutrition Disorders |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized controlled trial
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Double-blind
| Cow's milk-based infant formula | Dietary Supplement | Cow's milk-based infant formula formula fed at age appropriate quantities for 24 weeks |
|
| 24 weeks, measured monthly |
| WHO z-score of length-for-age | Body length without shoes, measured lying down to the nearest centimeter with a neonatometer. | 24 weeks, measured monthly |
| WHO z-score of head circumference-for-age | Head circumference measured with flexible non-stretching tape to the nearest centimeter. | 24 weeks, measured monthly |
| WHO z-score of weight-for-length | Weight and length measured as described above combined. | 24 weeks, measured monthly |