Infants Fed an Amino Acid-based Formula

Study Overview
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Brief Summary
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To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.

Official Title
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Symptom Changes in Infants Fed an Amino Acid-based Formula

Conditions
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Food Allergy

Intervention / Treatment
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* Other: Amino Acid-Based Experimental Study Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is judged to be in good health as determined from subject's medical history Subject is from a full-term birth with a gestational age of 37-42 weeks Subject's birth weight was ≥ 2490 g ( 5 lbs. 8 oz.) Subject has been documented to have CMPA and/or multiple food allergies, FPIES or gastrointestinal eosinophilic disorders. Subject is experiencing persistent feeding intolerance symptoms including any of the following: regurgitation/vomiting associated with feeding (within 1 hour), constipation, diarrhoea, hematochezia (blood in the stool), crying, gassiness (wind), and/or skin rash/eczema. Parent(s) confirm their intention to feed their infant study product during the study period. Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrolment through the duration of the study, unless instructed otherwise by their healthcare professional. Infant using medications (OTC medications for gas [wind]), home remedies (such as juice for constipation), herbal preparations, prebiotics, probiotics or rehydration fluids that might affect Gl tolerance may not be enrolled unless the parent agrees to discontinue the use of these agents prior to enrolment or a healthcare professional recommends their continued use. Subject's parent(s) has voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy regulation authorisation prior to any participation in the study. Exclusion Criteria: Subject is receiving steroids or antibiotics Subject is tube-fed Subject has received an amino acid-based formula Subject has been diagnosed with: Short bowel syndrome, Inflammatory bowel disease, Pancreatic disease, Protein maldigestion (malnutrition), Mast cell disorder Subject is participating in another study that has not been approved as a concomitant study by AN

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amino Acid-Based Experimental Study Formula<br>Single-Arm Study | Other: Amino Acid-Based Experimental Study Formula<br>* Amino Acid-Based Formula; fed ad libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Allergy Symptom Improvement | Parent Completed Symptom Diary | Baseline to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |