Status:
UNKNOWN
Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein
Lead Sponsor:
Laboratorios Ordesa
Conditions:
Infant Colic
Eligibility:
All Genders
2-8 years
Phase:
NA
Brief Summary
Randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from co...
Detailed Description
Demonstrate that an infant formula with partially hydrolized cow's milk protein of serum proteins is equivalent to an intact protein formula in healthy children in terms of safety of use and suitabili...
Eligibility Criteria
Inclusion
- Children diagnosed as nursing colic according to Roma IV criteria.
- Infants who have received breastfeeding at least 2 weeks.
- Infants who at the time of inclusion in the study whose parents/legal guardians voluntarily decide not to continue exclusive breastfeeding or only maintain it in residual form (less than 20% of the daily intake, one breast intake per day).
- Full-term infants (\>37 weeks of gestation).
- Infants with weight suitable for their gestational age (2500-4500g).
- Normal APGAR score: 7-10.
- Infants between 2 and 8 weeks of life.
- Infants whose parents/legal guardians have signed informed consent.
- Infants with good availability of clinical follow-up until the end of the study.
Exclusion
- Infants fed from birth with exclusive infant formula.
- Infants with congenital diseases or malformations that may affect growth.
- Infants with major medical conditions that require chronic medication or close medical checks.
- Infants who have taken any type of antibiotics or probiotics prior to the study.
Key Trial Info
Start Date :
July 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04015089
Start Date
July 19 2018
End Date
December 1 2020
Last Update
September 18 2020
Active Locations (2)
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1
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
2
Fundació Hospital de Nens
Barcelona, Spain, 08009