Clinical trial NCT06395571: GI Symptoms in Infants Fed GMF or CMF
Official title: Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula: a Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Infant Nutrition Disorders
Keywords: goat milk-based infant formula
infant formula
gastrointestinal comfort
infant nutrition
Lead sponsor: Ausnutria Hyproca B.V.
Sponsor class: INDUSTRY
First posted: 2024-05-02
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: 24 weeks, measured weekly
Secondary outcomes:
measure: Blood hemoglobin levels
timeFrame: 24 weeks, measured at start and end
measure: WHO z-score of weight-for-age
timeFrame: 24 weeks, measured monthly
measure: WHO z-score of length-for-age
timeFrame: 24 weeks, measured monthly
measure: WHO z-score of head circumference-for-age
timeFrame: 24 weeks, measured monthly
measure: WHO z-score of weight-for-length
timeFrame: 24 weeks, measured monthly
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Daycare center
state: Bahia
Study officials:
affiliation: Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil
name: Hugo da Costa Ribeiro, Dr.
role: PRINCIPAL_INVESTIGATOR
References: