Clinical trial NCT04015089: Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein
Official title: Randomized, Parallel, Double-blind Study With a Partially Hydrolyzed Infant Formula With Cow's Milk Protein vs a Formula With Intact Protein to Assess Growth and Impact on the Gastrointestinal Manifestations of Colic in the Healthy Infant.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Colic
Keywords: Infant formula
Partially hydrolized protein infant formula
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 156
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 colic

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

Eligibility criteria: 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.

Primary outcomes:
measure: Growth standard calculated z-scores
timeFrame: From baseline to 3 months after starting with the formula
measure: Symptoms associated with infant colic
timeFrame: From baseline to 3 months after starting with the formula
Secondary outcomes:
measure: Growth standard calculated z-scores
timeFrame: At 6, 9 and 12 months old.
measure: Gatrointestinal tolerance recording
timeFrame: Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old
measure: Infant illness and infection outcomes
timeFrame: Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old
measure: Behaviour/temperament test
timeFrame: 1, 6, 12 months old
measure: Assessment of supplementary food
timeFrame: At 6 and 9 months old
measure: Food survey at the first year of life
timeFrame: At 12 months old
measure: Product safety
timeFrame: At 1, 2 and 3 months follow-up visit, and 6, 9 months old
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: Fundació Hospital de Nens
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Benjamin Martin Martínez
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Hospital de Nens de Barcelona
name: Gemma Colomé Rivero
role: PRINCIPAL_INVESTIGATOR
References: