GI Symptoms in Infants Fed GMF or CMF

Gastrointestinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06395571
• Other study ID #: P19-009
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: October 6, 2019

Study information

• Verified date: April 2024
• Source: Ausnutria Hyproca B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 6, 2019
• Est. primary completion date: October 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Infant Nutrition Disorders
• Nutrition Disorders

Intervention

Dietary Supplement:
• Goat milk-based infant formula
Goat milk-based infant formula fed at age appropriate quantities for 24 weeks
• Cow's milk-based infant formula
Cow's milk-based infant formula formula fed at age appropriate quantities for 24 weeks

Locations

Country	Name	City	State
Brazil	Daycare center	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Ausnutria Hyproca B.V.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood hemoglobin levels	Blood hemoglobin levels before and after intervention	24 weeks, measured at start and end
Secondary	WHO z-score of weight-for-age	Weight measured to the nearest 5.0 grams with clothes and diaper removed.	24 weeks, measured monthly
Secondary	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
Secondary	WHO z-score of head circumference-for-age	Head circumference measured with flexible non-stretching tape to the nearest centimeter.	24 weeks, measured monthly
Secondary	WHO z-score of weight-for-length	Weight and length measured as described above combined.	24 weeks, measured monthly