GI Symptoms in Infants Fed GMF or CMF

Ausnutria Hyproca B.V.56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gastrointestinal Diseases Infant Nutrition Disorders

Interventions

Goat milk-based infant formulaDIETARY_SUPPLEMENT

Goat milk-based infant formula fed at age appropriate quantities for 24 weeks

Cow's milk-based infant formulaDIETARY_SUPPLEMENT

Cow's milk-based infant formula formula fed at age appropriate quantities for 24 weeks

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Daycare center

Salvador, Estado de Bahia, Brazil

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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