Food Allergy
Conditions
Brief summary
To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.
Interventions
OTHERAmino Acid-Based Experimental Study Formula
Amino Acid-Based Formula; fed ad libitum
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Allergy Symptom Improvement | Baseline to Day 28 | Parent Completed Symptom Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Symptom Resolution or Reduction | Baseline to Day 28 | Parent Completed Symptom Diary |
| Change in Length | Baseline to Day 28 | Length-for-age z scores |
| Change in Weight | Baseline to Day 28 | Weight-for-age z scores |
| Study Formula Intake | Baseline to Day 28 | Parent Completed Intake Diary |
Countries
United Kingdom
Outcome results
None listed