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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Infant Nutrition Disorders
• Intervention / Treatment: Dietary supplement: Goat milk-based infant formula; Dietary supplement: Cow's milk-based infant formula

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil
      • Daycare center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• gestational age 37-42 weeks
• 3-12 months old at enrollment
• should have consumed cow's milk-based products during the 48 hours prior to the baseline visit to exclude cow's milk allergic infants

Exclusion Criteria:

• metabolic or chronic disease or congenital malformation, serious concurrent illness that would interfere with study treatment, (i.e. sepsis, pneumonia with respiratory failure, cardiac failure)
• infant's parent(s) or primary caregiver(s) diagnosed with major depression
• infant's weight for length at baseline >|3| z-score indexes according to WHO criteria
• infants enrolled in another interventional clinical research study
• infants diagnosed with cow's milk allergies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goat milk-based infant formula; Experimental group receives goat milk-based formula for 24 weeks	Dietary supplement: Goat milk-based infant formula; Goat milk-based infant formula fed at age appropriate quantities for 24 weeks
Active Comparator: Cow's milk-based infant formula; Control group receives cow's milk-based formula 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Ausnutria Hyproca B.V.
• Investigators: Principal Investigator: Hugo da Costa Ribeiro, Dr., Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): October 6, 2019
• Study Completion (Actual): October 6, 2019

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: infant nutrition; infant formula; gastrointestinal comfort; goat milk-based infant formula
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Nutrition Disorders; Infant Nutrition Disorders
• Other Study ID Numbers: P19-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No