GI Symptoms in Infants Fed GMF or CMF

NCT ID: NCT06395571

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2019-10-06

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.

Conditions

Gastrointestinal Diseases; Infant Nutrition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Goat milk-based infant formula

Experimental group receives goat milk-based formula for 24 weeks

Group Type: EXPERIMENTAL

Goat milk-based infant formula

Intervention Type: DIETARY_SUPPLEMENT

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

Cow's milk-based infant formula

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

Group Type: ACTIVE_COMPARATOR

Cow's milk-based infant formula

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Goat milk-based infant formula

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

Intervention Type: DIETARY_SUPPLEMENT

Cow's milk-based infant formula

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ausnutria Hyproca B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugo da Costa Ribeiro, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil

Locations

Daycare center

Salvador, Estado de Bahia, Brazil

Countries

Brazil

References

Maximino P, van Lee L, Meijer-Krommenhoek YN, van der Zee L, da Costa Ribeiro Junior H. Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow's milk-based formula: a double-blind, randomized, controlled trial. BMC Pediatr. 2024 Nov 20;24(1):753. doi: 10.1186/s12887-024-05214-y.

Reference Type: DERIVED

PMID: 39567910 (View on PubMed)

Other Identifiers

P19-009

Identifier Type: -

Identifier Source: org_study_id