NCT06395571

GI Symptoms in Infants Fed GMF or CMF

Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula: a Double-blind, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Ausnutria Hyproca B.V. · Industry
• Sex: All
• Age: 3 Months – 12 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Gastrointestinal Diseases
• Infant Nutrition Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Goat milk-based infant formula	Goat milk-based infant formula fed at age appropriate quantities for 24 weeks
DIETARY_SUPPLEMENT	Cow's milk-based infant formula	Cow's milk-based infant formula formula fed at age appropriate quantities for 24 weeks

Timeline

• Start date: 2019-04-17
• Primary completion: 2019-10-06
• Completion: 2019-10-06
• First posted: 2024-05-02
• Last updated: 2024-05-02

Locations

1 site across 1 country: Brazil