Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein

Last updated: September 17, 2020
Sponsor: Laboratorios Ordesa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Treatment

N/A

Clinical Study ID

NCT04015089
EC-MAGICO-01-18
MAGICO
  • Ages < 8
  • All Genders

Study 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 colic

Eligibility Criteria

Inclusion

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 guardiansvoluntarily decide not to continue exclusive breastfeeding or only maintain it inresidual 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

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 medicalchecks.

  • Infants who have taken any type of antibiotics or probiotics prior to the study.

Study Design

Total Participants: 156
Study Start date:
July 19, 2018
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona 08227
    Spain

    Active - Recruiting

  • Fundació Hospital de Nens

    Barcelona, 08009
    Spain

    Site Not Available

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