Infant ColicVEGY-UPNCT04015089
Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein
A study testing Partially hydrolyzed formula (pHF) and Standard formula (SF) in people with Infant Colic, run by Laboratorios Ordesa at 2 sites in Spain.
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 Read more about this study
- Who is it for?
- Ages 2 to 8 weeks
- Conditions the study is for
- Infant Colic
- What is being tested?
- Partially hydrolyzed formula (pHF) and Standard formula (SF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesSpain
- Study dates
- 19 Jul 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 1 recruiting
- Active, not recruiting
Fundació Hospital de Nens
Barcelona, 08009
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Benjamin Martin, MD, 937310007, bmartingastro@hotmail.com
About this study
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.
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
Read the 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.
- Conditions
- Infant Colic
- Being tested
- Partially hydrolyzed formula (pHF), Standard formula (SF)
- Keywords
- Infant formula, Partially hydrolized protein infant formula
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially hydrolyzed formula (pHF)Dietary supplement
Infant formula with partially hydrolyzed protein
Standard formula (SF)Dietary supplement
Infant formula with intact protein
| Study group | Role | What they receive |
|---|---|---|
| Partially hydrolyzed formula (pHF) | Experimental | Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins. Receives: Dietary Supplement: Partially hydrolyzed formula (pHF) |
| Standard formula (SF) | Active comparator | Infants fed exclusively with a standard formula based on intact cow's milk proteins Receives: Dietary Supplement: Standard formula (SF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth standard calculated z-scores
Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)
Measured: 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
Measured: From baseline to 3 months after starting with the formula
Secondary outcomes (7)
Growth standard calculated z-scores
Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)
Measured: At 6, 9 and 12 months old.
Gatrointestinal tolerance recording
Record in the patient's diary stool patterns (depositional rhythm and quality of faeces)
Measured: 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)
Measured: 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.
Measured: 1, 6, 12 months old
Assessment of supplementary food
Investigator will collect data from the timetable for introduction of the different food groups
Measured: At 6 and 9 months old
Food survey at the first year of life
Investigator will conduct a food consumption frequency survey
Measured: 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.
Measured: At 1, 2 and 3 months follow-up visit, and 6, 9 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start19 Jul 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin Martin Martínez, Principal investigator, Consorci Sanitari de TerrassaGemma Colomé Rivero, Principal investigator, Fundació Hospital de Nens de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015089
- Sponsor's protocol ID
- EC-MAGICO-01-18
- Other IDs
- MAGICO
- Acronym
- VEGY-UP
- Status last verified
- Sep 2020
- First submitted
- 8 Jul 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04015089
- Acronym / sponsor ID
- VEGY-UP / EC-MAGICO-01-18
- Conditions
- Infant Colic
- Keywords
- Infant formula, Partially hydrolized protein infant formula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partially hydrolyzed formula (pHF) | Experimental | Dietary Supplement: Partially hydrolyzed formula (pHF)Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins. |
| Standard formula (SF) | Active comparator | Dietary Supplement: Standard formula (SF)Infants fed exclusively with a standard formula based on intact cow's milk proteins |
Who may qualify
- Ages
- 2 to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partially hydrolyzed formula (pHF)Infant formula with partially hydrolyzed protein | Dietary supplement | Partially hydrolyzed formula (pHF) |
| Standard formula (SF)Infant formula with intact protein | Dietary supplement | Standard formula (SF) |
Primary outcome
Growth standard calculated z-scores
Time frame: From baseline to 3 months after starting with the formula
Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)
Symptoms associated with infant colic
Time frame: From baseline to 3 months after starting with the formula
Hours of crying, wakefulness, sleep for 24 hours, by adapting Barr's crying letter
7 secondary outcomes
Growth standard calculated z-scores
Time frame: At 6, 9 and 12 months old.
Gatrointestinal tolerance recording
Time frame: Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old
Infant illness and infection outcomes
Time frame: Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old
Behaviour/temperament test
Time frame: 1, 6, 12 months old
Assessment of supplementary food
Time frame: At 6 and 9 months old
Food survey at the first year of life
Time frame: At 12 months old
Product safety
Time frame: At 1, 2 and 3 months follow-up visit, and 6, 9 months old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Martin Martínez principal investigator
Consorci Sanitari de Terrassa
Gemma Colomé Rivero principal investigator
Fundació Hospital de Nens de Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially hydrolyzed formula (pHF) and Standard formula (SF) in people with Infant Colic, run by Laboratorios Ordesa at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roser De Castellar, MD (+34 902105243, Roser.DeCastellar@ordesa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth standard calculated z-scores (time frame: From baseline to 3 months after starting with the formula). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.