An interventional study of Goat milk-based infant formula and Cow's milk-based infant formula in Gastrointestinal Diseases and Infant Nutrition Disorders, sponsored by Ausnutria Hyproca B.V.. Completed at 1 site in Brazil. Open to participants aged 3 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Ausnutria Hyproca B.V. · Not applicable, Interventional, and Treatment
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.
639 studies on the registry are indexed under Gastrointestinal Diseases; 126 are open to participants now.
This study's enrollment of 56 is below the median of 77 across 428 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Ausnutria Hyproca B.V. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Experimental group receives goat milk-based formula for 24 weeks
Dietary Supplement: Goat milk-based infant formula
Control group receives cow's milk-based formula for 24 weeks
Dietary Supplement: Cow's milk-based infant formula
Goat milk-based infant formula fed at age appropriate quantities for 24 weeks
Cow's milk-based infant formula formula fed at age appropriate quantities for 24 weeks
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.
Time frame: 24 weeks, measured weekly
Blood hemoglobin levels
Blood hemoglobin levels before and after intervention
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks, measured monthly
WHO z-score of head circumference-for-age
Head circumference measured with flexible non-stretching tape to the nearest centimeter.
Time frame: 24 weeks, measured monthly
WHO z-score of weight-for-length
Weight and length measured as described above combined.
Time frame: 24 weeks, measured monthly
Plan to share: No
Ran from Apr 2019 to primary completion in Oct 2019, 5 months.
Of 176 interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 5 months is below that.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Ausnutria Hyproca B.V.