Infants Fed an Amino Acid-based Formula

Abbott

Status

Terminated

Conditions

Food Allergy

Treatments

Other: Amino Acid-Based Experimental Study Formula

Study type

Interventional

Funder types

Industry

Identifiers

AL28

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

Under 12 months old

Volunteers

No Healthy Volunteers

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