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Completed

NCT Number: NCT06395571

GI Symptoms in Infants Fed GMF or CMF

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.

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Key information

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daycare center

Salvador, Estado de Bahia, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goat milk-based infant formula

Dietary Supplement

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

Cow's milk-based infant formula

Dietary Supplement

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

Primary outcomes

  1. Gastrointestinal symptoms

    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.

Secondary outcomes

  1. Blood hemoglobin levels

    Time frame: 24 weeks, measured at start and end

    Blood hemoglobin levels before and after intervention

  2. WHO z-score of weight-for-age

    Time frame: 24 weeks, measured monthly

    Weight measured to the nearest 5.0 grams with clothes and diaper removed.

  3. WHO z-score of length-for-age

    Time frame: 24 weeks, measured monthly

    Body length without shoes, measured lying down to the nearest centimeter with a neonatometer.

  4. WHO z-score of head circumference-for-age

    Time frame: 24 weeks, measured monthly

    Head circumference measured with flexible non-stretching tape to the nearest centimeter.

  5. WHO z-score of weight-for-length

    Time frame: 24 weeks, measured monthly

    Weight and length measured as described above combined.

Sponsors and collaborators

Lead sponsor

Ausnutria Hyproca B.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 2, 2024
Registry last updated
May 2, 2024

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.

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