Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sprim Advanced Life Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frisolac Gold Intensive HA | Other | Regular medical care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth |
| 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 (%) | Can be 2 weeks up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Type of symptoms | Type of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis) | Can be 2 weeks up to 2 months |
| Number of symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Mexican children (≤24 months) diagnosed with or suspected of CMPA.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rosa E Huerta Hernandez, MD | Clínica de Alergia Pediátrica, México | Principal Investigator |
| Benjamin Zepeda Ortega, MD | Clinica San Antonio, Mexico | Principal Investigator |
| Marlene Ruiz Castillo, MD | Hospital del Niño DIF Hildago, Mexico; Consultorio de Pediatría Pachuca, Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica San Antonio | Mexico City | Mexico | ||||
| Clínica de Alergia Pediátrica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36793546 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Number of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)
| Can be 2 weeks up to 2 months |
| Severity of symptoms | Severity of symptoms on first and second visit (based on clinical diagnosis) | Can be 2 weeks up to 2 months |
| Pachuca |
| Mexico |
| Consultorio de Pediatria | Pachuca | Mexico |
| Hospital del Niño DIF | Pachuca | Mexico |