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

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.

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

Study Overview

• Status: Unknown
• Conditions: Infant Colic
• Intervention / Treatment: Dietary supplement: Partially hydrolyzed formula (pHF); Dietary supplement: Standard formula (SF)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08009
    • Active, not recruiting
    • Fundació Hospital de Nens
  • Barcelona
    • Terrassa, Barcelona, Spain, 08227
      • Recruiting
      • Consorci Sanitari de Terrassa
      • Contact: Benjamin Martin, MD; Phone Number: 937310007; Email: bmartingastro@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Partially hydrolyzed formula (pHF); Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins.	Dietary supplement: Partially hydrolyzed formula (pHF); Infant formula with partially hydrolyzed protein
ACTIVE_COMPARATOR: Standard formula (SF); Infants fed exclusively with a standard formula based on intact cow's milk proteins	Dietary supplement: Standard formula (SF); Infant formula with intact protein

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Investigators: Principal Investigator: Benjamin Martin Martínez, Consorci Sanitari de Terrassa; Principal Investigator: Gemma Colomé Rivero, Fundació Hospital de Nens de Barcelona

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2018
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (ACTUAL): July 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Infant formula; Partially hydrolized protein infant formula
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: EC-MAGICO-01-18; MAGICO (OTHER: Ordesa)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No