Daycare center
Salvador, Estado de Bahia, Brazil
NCT Number: NCT06395571
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.
Looking for future studies?
Notify Me3 month–12 month
All sexes
Interventional
Not applicable
Salvador, Estado de Bahia, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 24 weeks, measured weekly
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 at start and end
Blood hemoglobin levels before and after intervention
Time frame: 24 weeks, measured monthly
Weight measured to the nearest 5.0 grams with clothes and diaper removed.
Time frame: 24 weeks, measured monthly
Body length without shoes, measured lying down to the nearest centimeter with a neonatometer.
Time frame: 24 weeks, measured monthly
Head circumference measured with flexible non-stretching tape to the nearest centimeter.
Time frame: 24 weeks, measured monthly
Weight and length measured as described above combined.
Ausnutria Hyproca B.V.
Industry
Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula: a Double-blind, Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06286865
Digestive System Diseases, Gastrointestinal Diseases
Tromsø, Troms, Norway
View Trial DetailsNCT06159088
Digestive System Diseases, Gastrointestinal Diseases
Jinhua, Zhejiang, China
View Trial DetailsNCT01697397
Colonic Diseases, Colonic Diseases, Functional
Mountain View, California, United States
View Trial DetailsNCT05298774
Digestive System Diseases, Gastrointestinal Diseases
New Haven, Connecticut, United States
View Trial Details