Gastrointestinal Diseases, Infant Nutrition Disorders
Conditions
Keywords
goat milk-based infant formula, infant formula, gastrointestinal comfort, infant nutrition
Brief 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.
Interventions
DIETARY_SUPPLEMENTGoat milk-based infant formula
Goat milk-based infant formula fed at age appropriate quantities for 24 weeks
DIETARY_SUPPLEMENTCow's milk-based infant formula
Cow's milk-based infant formula formula fed at age appropriate quantities for 24 weeks
Sponsors
Ausnutria Hyproca B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood hemoglobin levels | 24 weeks, measured at start and end | Blood hemoglobin levels before and after intervention |
| WHO z-score of weight-for-age | 24 weeks, measured monthly | Weight measured to the nearest 5.0 grams with clothes and diaper removed. |
| WHO z-score of length-for-age | 24 weeks, measured monthly | Body length without shoes, measured lying down to the nearest centimeter with a neonatometer. |
| WHO z-score of head circumference-for-age | 24 weeks, measured monthly | Head circumference measured with flexible non-stretching tape to the nearest centimeter. |
| WHO z-score of weight-for-length | 24 weeks, measured monthly | Weight and length measured as described above combined. |
Countries
Brazil
Outcome results
None listed