Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Poor recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.
A range of clinical outcomes will be collected from the medical records and in-person assessment of 60 fully or partially formula fed infants (aged <13 months) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of cow's milk allergy
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoallergenic formula containing synbiotics | Infants (aged <13 months) with cow's milk allergy (CMA) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of CMA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoallergenic formula containing synbiotics | Other | An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare use | Data on the changes in healthcare use will be collected from medical records | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical impact and acceptability | Clinical outcomes related to CMA and parent/carer and infant acceptability will be assessed | 12 months post initiation of hypoallergenic formula containing synbiotics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Exclusively or partially formula fed infants with confirmed or suspected CMA who have been prescribed hypoallergenic formula containing synbiotics for the management of CMA as part of clinical care.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Nutricia UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adam Practice | Poole | United Kingdom |
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