Cow's Milk Protein AllergyFriso02NCT04596059
The Journey of Children With Cow's Milk Protein Allergy in Mexico.
An observational study of Cow's Milk Protein Allergy, run by FrieslandCampina at 4 sites in Mexico.
Trial summary
To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e. Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Cow's Milk Protein Allergy
- What is being tested?
- Frisolac Gold Intensive HA
- How many people
- 79 participants
- Where
- 4 sitesMexico
- Study dates
- 1 Oct 2020to 31 May 2021
- Phase
- Observational
- 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 0 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Mexican children (≤24 months) diagnosed with or suspected of CMPA.
Who may be able to join
- Subjects with electronic/physical medical records that contain sufficient data to answer the primary question (i.e. data on growth and dermatological symptoms (based on the SCORAD score) at diagnosis and follow up data of at least 2 months or successful completion of therapy according to the PI (whichever comes first).
- Subjects ≤24 months of age at the moment of suspected or diagnosed CMPA with records available between January 2016 to September 2020.
- Subjects prescribed with Frisolac Gold Intensive HA and/or Frisolac Gold PEP AC for the dietary management of their CMPA symptoms.
Who cannot join
- Subjects using other formula products/breast milk alongside Frisolac Gold Intensive HA or Frisolac Gold PEP AC during the time of their participation in the study.
- Premature children, or children with low birth-weight (weight at birth <2.5 kg).
- Subjects diagnosed with a metabolic condition that impacts development and growth.
- Subjects diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the PI could potentially interfere with their participation in the study.
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites
Clinica San Antonio
Mexico City
Clínica de Alergia Pediátrica
Pachuca
Consultorio de Pediatria
Pachuca
Hospital del Niño DIF
Pachuca
About this study
Official title: A Retrospective and Comparative Study on the Journey of Children With Cow´s Milk Protein Allergy in Mexico: Current Practice in Allergy Management in Mexican Children Aged ≤24 Months
To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e. diagnosis and dietary management) of CMPA in Mexican children (≤24 months) diagnosed with or suspected of CMPA.
- Conditions
- Cow's Milk Protein Allergy
- Being tested
- Frisolac Gold Intensive HA
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frisolac Gold Intensive HAOther
Also called Frisolac Gold PEP AC
Regular medical care
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
- the proportion of subjects with weight gain compared to the previous visit (%)
- the proportion of subjects with height gain compared to the previous visit (%)
- the proportion of subjects with both weight and height gain compared to the previous visit (%)
Measured: Can be 2 weeks up to 2 months
Dermatological symptoms (SCORAD score)
The proportion of subjects with an 1-point improvement in their SCORAD intensity category in between 2 visits (%)
Measured: Can be 2 weeks up to 2 months
Secondary outcomes (3)
Type of symptoms
Type of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)
Measured: Can be 2 weeks up to 2 months
Number of symptoms
Number of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)
Measured: Can be 2 weeks up to 2 months
Severity of symptoms
Severity of symptoms on first and second visit (based on clinical diagnosis)
Measured: Can be 2 weeks up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Oct 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cow's Milk Protein AllergyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- Rosa E Huerta Hernandez, MD, Principal investigator, Clínica de Alergia Pediátrica, MéxicoBenjamin Zepeda Ortega, MD, Principal investigator, Clinica San Antonio, MexicoMarlene Ruiz Castillo, MD, Principal investigator, Hospital del Niño DIF Hildago, Mexico; Consultorio de Pediatría Pachuca, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596059
- Sponsor's protocol ID
- CEI00320171130/07/052020
- Acronym
- Friso02
- Status last verified
- Aug 2021
- First submitted
- 2 Oct 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Estrada Reyes E, Zepeda Ortega B, Ten Haaf D, Kudla U, Muhardi L, Hofman DL, Hageman JHJ, Huerta Hernandez RE. Symptom's resolution and growth outcome of children with cow's milk protein allergy consuming two hydrolyzed formulas: A retrospective study in Mexico. Front Allergy. 2023 Jan 30;4:1073430. doi: 10.3389/falgy.2023.1073430. eCollection 2023.
PubMed 36793546
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Comparative Study on the Journey of Children With Cow´s Milk Protein Allergy in Mexico: Current Practice in Allergy Management in Mexican Children Aged ≤24 Months
- ClinicalTrials.gov ID
- NCT04596059
- Acronym / sponsor ID
- Friso02 / CEI00320171130/07/052020
- Conditions
- Cow's Milk Protein Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 22 Oct 2020 (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.
To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e. diagnosis and dietary management) of CMPA in Mexican children (≤24 months) diagnosed with or suspected of CMPA.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Mexican children (≤24 months) diagnosed with or suspected of CMPA.
Key inclusion criteria (3 listed)
- Subjects with electronic/physical medical records that contain sufficient data to answer the primary question (i.e. data on growth and dermatological symptoms (based on the SCORAD score) at diagnosis and follow up data of at least 2 months or successful completion of therapy according to the PI (whichever comes first).
- Subjects ≤24 months of age at the moment of suspected or diagnosed CMPA with records available between January 2016 to September 2020.
- Subjects prescribed with Frisolac Gold Intensive HA and/or Frisolac Gold PEP AC for the dietary management of their CMPA symptoms.
Key exclusion criteria (4 listed)
- Subjects using other formula products/breast milk alongside Frisolac Gold Intensive HA or Frisolac Gold PEP AC during the time of their participation in the study.
- Premature children, or children with low birth-weight (weight at birth <2.5 kg).
- Subjects diagnosed with a metabolic condition that impacts development and growth.
- Subjects diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the PI could potentially interfere with their participation in 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 |
|---|---|---|
| Frisolac Gold Intensive HAAlso: Frisolac Gold PEP ACRegular medical care | Other | – |
Primary outcome
Growth
Time frame: Can be 2 weeks up to 2 months
* the proportion of subjects with weight gain compared to the previous visit (%) * the proportion of subjects with height gain compared to the previous visit (%) * the proportion of subjects with both weight and height gain compared to the previous visit (%)
Dermatological symptoms (SCORAD score)
Time frame: Can be 2 weeks up to 2 months
The proportion of subjects with an 1-point improvement in their SCORAD intensity category in between 2 visits (%)
3 secondary outcomes
Type of symptoms
Time frame: Can be 2 weeks up to 2 months
Number of symptoms
Time frame: Can be 2 weeks up to 2 months
Severity of symptoms
Time frame: Can be 2 weeks up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Derived from this study: PubMed 36793546Estrada Reyes E, Zepeda Ortega B, Ten Haaf D, Kudla U, Muhardi L, Hofman DL, Hageman JHJ, Huerta Hernandez RE. Symptom's resolution and growth outcome of children with cow's milk protein allergy consuming two hydrolyzed formulas: A retrospective study in Mexico. Front Allergy. 2023 Jan 30;4:1073430. doi: 10.3389/falgy.2023.1073430. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Rosa E Huerta Hernandez, MD principal investigator
Clínica de Alergia Pediátrica, México
Benjamin Zepeda Ortega, MD principal investigator
Clinica San Antonio, Mexico
Marlene Ruiz Castillo, MD principal investigator
Hospital del Niño DIF Hildago, Mexico; Consultorio de Pediatría Pachuca, Mexico
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Protein Allergy, run by FrieslandCampina at 4 sites in Mexico.
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 3 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: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth (time frame: Can be 2 weeks up to 2 months). 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?
On the ClinicalTrials.gov record for NCT04596059, which also lists 1 linked publication.
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 27 Aug 2021.