NCT06395571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2019

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 26, 2024

Last Update Submit

April 30, 2024

Conditions

Gastrointestinal DiseasesInfant Nutrition Disorders

Keywords

goat milk-based infant formulainfant formulagastrointestinal comfortinfant nutrition

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal symptoms

    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.

    24 weeks, measured weekly

Secondary Outcomes (5)

  • Blood hemoglobin levels

    24 weeks, measured at start and end

  • WHO z-score of weight-for-age

    24 weeks, measured monthly

  • WHO z-score of length-for-age

    24 weeks, measured monthly

  • WHO z-score of head circumference-for-age

    24 weeks, measured monthly

  • WHO z-score of weight-for-length

    24 weeks, measured monthly

Study Arms (2)

Goat milk-based infant formula

EXPERIMENTAL

Experimental group receives goat milk-based formula for 24 weeks

Dietary Supplement: Goat milk-based infant formula

Cow's milk-based infant formula

ACTIVE COMPARATOR

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

Dietary Supplement: Cow's milk-based infant formula

Interventions

Goat milk-based infant formulaDIETARY_SUPPLEMENT

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

Goat milk-based infant formula
Cow's milk-based infant formulaDIETARY_SUPPLEMENT

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

Cow's milk-based infant formula

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • gestational age 37-42 weeks
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daycare center

Salvador, Estado de Bahia, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 39567910DERIVED

MeSH Terms

Conditions

Gastrointestinal DiseasesInfant Nutrition Disorders

Condition Hierarchy (Ancestors)

Digestive System DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Hugo da Costa Ribeiro, Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 2, 2024

Study Start

April 17, 2019

Primary Completion

October 6, 2019

Study Completion

October 6, 2019

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)