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

Laboratorios Ordesa156 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

156

Conditions

Infant Colic

Interventions

Partially hydrolyzed formula (pHF)DIETARY_SUPPLEMENT

Infant formula with partially hydrolyzed protein

Standard formula (SF)DIETARY_SUPPLEMENT

Infant formula with intact protein

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 8 Weeks

Medical Language ↔ Plain English

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.

Locations (2)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

RECRUITING

Fundació Hospital de Nens

Barcelona, Spain

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

Growth standard calculated z-scores

Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)

Time frame: From baseline to 3 months after starting with the formula

Symptoms associated with infant colic

Hours of crying, wakefulness, sleep for 24 hours, by adapting Barr's crying letter

Time frame: From baseline to 3 months after starting with the formula

Secondary Outcomes

Growth standard calculated z-scores

Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)

Time frame: At 6, 9 and 12 months old.

Gatrointestinal tolerance recording

Record in the patient's diary stool patterns (depositional rhythm and quality of faeces)

Time frame: Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old

Infant illness and infection outcomes

Specific parent-reported infant symptoms (digestive, respiratory or other infections)

Time frame: Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old

Behaviour/temperament test

Infant Behavior Questionnaire-Revised test: For this study, the very short form validated in Spanish that includes 37 items will be applied. Parents are asked to rate the frequency of specific, temperament-related behaviors observed during the last week.

Time frame: 1, 6, 12 months old

Assessment of supplementary food

Investigator will collect data from the timetable for introduction of the different food groups

Central Contacts

Roser De Castellar, MD

CONTACT

+34 902105243 Roser.DeCastellar@ordesa.es

Data from ClinicalTrials.gov

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