Goat Milk Infant Formula Comfort Study
Clinical Trial to Assess Improvement of Digestive Symptoms With Goat's Milk Infant Formula.
1 other identifier
interventional
18
1 country
1
Brief Summary
In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
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
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedMarch 8, 2024
March 1, 2024
1.9 years
February 28, 2024
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Cow's Milk-related Symptoms
Difference in Cow's Milk related Symptom Score (CoMiSS: score ranges from 0 to 33 with higher scores indicating more symptoms) at baseline and after 14 days of intervention.
0-2 weeks
Secondary Outcomes (8)
Cow's Milk-related Symptoms
0-4 weeks
Parental stress
0-4 weeks
Parental quality of life
0-4 weeks
Weight
0-4 weeks
Length
0-4 weeks
- +3 more secondary outcomes
Study Arms (2)
Goat milk-based formula
EXPERIMENTALgoat milk-based infant formula (GMF)
Cow's milk-based formula
PLACEBO COMPARATORcow's milk-based infant formula supplemented with probiotics (CMFp)
Interventions
Infant formula based on goat milk for 4 weeks at volume depending on the infant
Infant formula based on cow's milk with probiotic Lactobacillus reuteri drops for 4 weeks at volume depending on the infant
Eligibility Criteria
You may qualify if:
- Healthy full-term infant with birth weight ≥2,500 to ≤4,500 g
- Infant aged between 4 weeks and 3 months at enrolment
- CoMiSS value at baseline between 6 and 12
- Infant is exclusively bottle fed with cow's milk based infant formula at baseline
You may not qualify if:
- Breastfed infants
- Congenital illness or malformation that may affect infant feeding or normal growth
- Gastrointestinal disorders
- Confirmed cow or goat milk protein allergy or lactose intolerance
- Supplemental feeding
- Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrolment
- Infant participating in another clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ausnutria Hyproca B.V.lead
- HM hospitalescollaborator
Study Sites (1)
HM hospitales
Madrid, 28015, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alejandro López-Escobar, Dr.
Hospital Universitario General de Villalba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 8, 2024
Study Start
May 1, 2019
Primary Completion
April 1, 2021
Study Completion
February 1, 2024
Last Updated
March 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share