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Insufficient recruitment
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To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino Acid-Based Experimental Study Formula | Experimental | Single-Arm Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acid-Based Experimental Study Formula | Other | Amino Acid-Based Formula; fed ad libitum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Food Allergy Symptom Improvement | Parent Completed Symptom Diary | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Symptom Resolution or Reduction | Parent Completed Symptom Diary | Baseline to Day 28 |
| Change in Length | Length-for-age z scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Kajzer, MS, RD, LD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Adam Practice | Poole | BH15 4JQ | United Kingdom | |||
| University Hospital Southampton NHS Foundation Trust |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Baseline to Day 28 |
| Change in Weight | Weight-for-age z scores | Baseline to Day 28 |
| Study Formula Intake | Parent Completed Intake Diary | Baseline to Day 28 |
| Southampton |
| SO16 6YD |
| United Kingdom |
| Royal London Hospital | Whitechapel | E1 1BB | United Kingdom |