Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein (VEGY-UP)
Primary Purpose
Infant Colic
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Partially hydrolyzed formula (pHF)
Standard formula (SF)
Sponsored by
About this trial
This is an interventional supportive care trial for Infant Colic focused on measuring Infant formula, Partially hydrolized protein infant formula
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.
Sites / Locations
- Consorci Sanitari de TerrassaRecruiting
- Fundació Hospital de Nens
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Partially hydrolyzed formula (pHF)
Standard formula (SF)
Arm Description
Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins.
Infants fed exclusively with a standard formula based on intact cow's milk proteins
Outcomes
Primary Outcome Measures
Growth standard calculated z-scores
Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)
Symptoms associated with infant colic
Hours of crying, wakefulness, sleep for 24 hours, by adapting Barr's crying letter
Secondary Outcome Measures
Growth standard calculated z-scores
Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)
Gatrointestinal tolerance recording
Record in the patient's diary stool patterns (depositional rhythm and quality of faeces)
Infant illness and infection outcomes
Specific parent-reported infant symptoms (digestive, respiratory or other infections)
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.
Assessment of supplementary food
Investigator will collect data from the timetable for introduction of the different food groups
Food survey at the first year of life
Investigator will conduct a food consumption frequency survey
Product safety
Assessment of acceptance of the formula and record of potential adverse or side effects related to taking the product.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04015089
Brief Title
Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Colic
Keywords
Infant formula, Partially hydrolized protein infant formula
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partially hydrolyzed formula (pHF)
Arm Type
Experimental
Arm Description
Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins.
Arm Title
Standard formula (SF)
Arm Type
Active Comparator
Arm Description
Infants fed exclusively with a standard formula based on intact cow's milk proteins
Intervention Type
Dietary Supplement
Intervention Name(s)
Partially hydrolyzed formula (pHF)
Intervention Description
Infant formula with partially hydrolyzed protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard formula (SF)
Intervention Description
Infant formula with intact protein
Primary Outcome Measure Information:
Title
Growth standard calculated z-scores
Description
Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)
Time Frame
From baseline to 3 months after starting with the formula
Title
Symptoms associated with infant colic
Description
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 Outcome Measure Information:
Title
Growth standard calculated z-scores
Description
Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)
Time Frame
At 6, 9 and 12 months old.
Title
Gatrointestinal tolerance recording
Description
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
Title
Infant illness and infection outcomes
Description
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
Title
Behaviour/temperament test
Description
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
Title
Assessment of supplementary food
Description
Investigator will collect data from the timetable for introduction of the different food groups
Time Frame
At 6 and 9 months old
Title
Food survey at the first year of life
Description
Investigator will conduct a food consumption frequency survey
Time Frame
At 12 months old
Title
Product safety
Description
Assessment of acceptance of the formula and record of potential adverse or side effects related to taking the product.
Time Frame
At 1, 2 and 3 months follow-up visit, and 6, 9 months old
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roser De Castellar, MD
Phone
+34 902105243
Email
Roser.DeCastellar@ordesa.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Martin Martínez
Organizational Affiliation
Consorci Sanitari de Terrassa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gemma Colomé Rivero
Organizational Affiliation
Fundació Hospital de Nens de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Martin, MD
Phone
937310007
Email
bmartingastro@hotmail.com
Facility Name
Fundació Hospital de Nens
City
Barcelona
ZIP/Postal Code
08009
Country
Spain
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
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Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein
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