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The main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food for Specific Medical Purpose | Other | Infants aged 1 to 8 months with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides |
| Measure | Description | Time Frame |
|---|---|---|
| The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard | Weight gain will be measured in kg and converted to WAZ scores | Comparison of baseline WAZ vs WAZ at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length-for-age Z-scores (LAZ) compared with the WHO 2006 Child Growth Standard | Body length will be measured in cm and converted to LAZ scores | 1, 2, 3, 4 months from baseline and at 12 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Head circumference (HCAZ) compared with the WHO 2006 Child Growth Standard | Head circumference will be measured in cm converted to HCAZ scores | 1, 2, 3, 4 months from baseline and at 12 months of age |
| Monitoring of CMPA-related symptoms |
Inclusion Criteria:
Exclusion Criteria:
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Full-term infants 1-8 months of age with symptoms suggestive of moderate-to-severe CMPA who have failed a trial of extensively hydrolyzed formula (EHF) of at least 2 weeks or who require amino acid formula as first line of treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital at Westmead | Sydney | Westmead | 2145 | Australia |
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| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Stool samples
CMPA-related symptoms will be documented by the study physician on data collection forms
| 1, 2, 3 and 4 months from baseline and at 12 months of age |
| Faecal microbial composition | Faecal samples will be collected before and after the study formula ingestion | Enrolment,1, 2, 3 and 4 months from treatment start and also at 12 months of age |
| Product compliance | Daily quantity consumed (mL) will be recorded for the 3 days preceding each visit in a diary given to the parent or caregiver | 1, 2, 3 and 4 months from baseline and at 12 months of age |