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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Infant Colic

Intervention / Treatment
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* Dietary Supplement: Partially hydrolyzed formula (pHF)
* Dietary Supplement: Standard formula (SF)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partially hydrolyzed formula (pHF)<br>Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins. | Dietary Supplement: Partially hydrolyzed formula (pHF)<br>* Infant formula with partially hydrolyzed protein<br>|
| Active Comparator: Standard formula (SF)<br>Infants fed exclusively with a standard formula based on intact cow's milk proteins | Dietary Supplement: Standard formula (SF)<br>* Infant formula with intact protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth standard calculated z-scores | Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm) | 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 | From baseline to 3 months after starting with the formula | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth standard calculated z-scores | Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm) | At 6, 9 and 12 months old. | 
| Gatrointestinal tolerance recording | Record in the patient's diary stool patterns (depositional rhythm and quality of faeces) | 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) | 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. | 1, 6, 12 months old | 
| Assessment of supplementary food | Investigator will collect data from the timetable for introduction of the different food groups | At 6 and 9 months old | 
| Food survey at the first year of life | Investigator will conduct a food consumption frequency survey | At 12 months old | 
| Product safety | Assessment of acceptance of the formula and record of potential adverse or side effects related to taking the product. | At 1, 2 and 3 months follow-up visit, and 6, 9 months old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant formula, Partially hydrolized protein infant formula