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

Infant Colic Clinical Trial

— VEGY-UP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04015089
• Other study ID #: EC-MAGICO-01-18
• Secondary ID: MAGICO
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Laboratorios Ordesa
• Contact: Roser De Castellar, MD
• Phone: +34 902105243
• Email: Roser.DeCastellar[@]ordesa.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Infant Colic

Intervention

Dietary Supplement:
• Partially hydrolyzed formula (pHF)
Infant formula with partially hydrolyzed protein
• Standard formula (SF)
Infant formula with intact protein

Locations

Country	Name	City	State
Spain	Fundació Hospital de Nens	Barcelona
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Ordesa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Growth standard calculated z-scores	Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)	At 6, 9 and 12 months old.
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of supplementary food	Investigator will collect data from the timetable for introduction of the different food groups	At 6 and 9 months old
Secondary	Food survey at the first year of life	Investigator will conduct a food consumption frequency survey	At 12 months old
Secondary	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