GI Symptoms in Infants Fed GMF or CMF

Ausnutria Hyproca

Status: Completed

Conditions: Gastrointestinal Diseases; Infant Nutrition Disorders

Treatments: Dietary Supplement: Cow's milk-based infant formula; Dietary Supplement: Goat milk-based infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT06395571

P19-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

56 participants in 2 patient groups

Goat milk-based infant formula

Experimental group

Description:

Experimental group receives goat milk-based formula for 24 weeks

Treatment:

Dietary Supplement: Goat milk-based infant formula

Cow's milk-based infant formula

Active Comparator group

Description:

Control group receives cow's milk-based formula for 24 weeks

Treatment:

Dietary Supplement: Cow's milk-based infant formula