Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein (VEGY-UP)

Laboratorios Ordesa

Status: Unknown

Conditions: Infant Colic

Treatments: Dietary Supplement: Partially hydrolyzed formula (pHF); Dietary Supplement: Standard formula (SF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04015089

EC-MAGICO-01-18

MAGICO (Other Identifier)

Details and patient eligibility

About

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 colic

Full 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 suitability, to prove that it can be a alternative with digestive health benefits in healthy children with infant colic.

Enrollment: 156 estimated patients

Sex: All

Ages: 2 to 8 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 2 patient groups

Partially hydrolyzed formula (pHF)

Experimental group

Description:

Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins.

Treatment:

Dietary Supplement: Partially hydrolyzed formula (pHF)

Standard formula (SF)

Active Comparator group

Description:

Infants fed exclusively with a standard formula based on intact cow's milk proteins

Treatment:

Dietary Supplement: Standard formula (SF)