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The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.
Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino acid based formula | Active Comparator | Patients will be randomised to one of two arms: Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula |
|
| New amino acid based formula | Active Comparator | Patients will be randomised to one of two arms: Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Special Medical Food | Other | Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months. Infants should typically consume the following amounts of formula during the study > 500mls/day up to 12 months of age > 400mls/day between 12 and 18 months of age > 300mls/day over 18 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate maturation of the GI immune system in IgE mediated CMA To confirm that the test formula is effective in the dietary management of CMA To assess frequency of other allergies | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Beyer, MD | Hospital Charité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| l'hôpital Necker Enfants malades | Paris | 75743 | France | |||
| Hospital Charité |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33006765 | Derived | Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2. |
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|
|
| Special Medical Food | Other | Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months. Infants should typically consume the following amounts of formula during the study > 500mls/day up to 12 months of age > 400mls/day between 12 and 18 months of age > 300mls/day over 18 months of age. |
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| Berlin |
| D-13353 |
| Germany |
| St.-Marien-Hospital | Bonn | 53115 | Germany |
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom |
| David Hyde Allergy Clinic - St. Mary's hospital | Newport | Isle of Wight | PO30 5TG | United Kingdom |
| Evelina Children's Hospital - St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| Newcastle general hospital | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D006969 | Hypersensitivity, Immediate |
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