Status:
TERMINATED
Infants Fed an Amino Acid-based Formula
Lead Sponsor:
Abbott Nutrition
Conditions:
Food Allergy
Eligibility:
All Genders
Up to 12 years
Phase:
NA
Brief Summary
To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04127656
Start Date
December 16 2019
End Date
December 16 2021
Last Update
April 27 2022
Active Locations (3)
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1
The Adam Practice
Poole, United Kingdom, BH15 4JQ
2
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
3
Royal London Hospital
Whitechapel, United Kingdom, E1 1BB