Infants Fed an Amino Acid-based Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2021-12-16

Brief Summary

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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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Detailed Description

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Conditions

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Food Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Amino Acid-Based Experimental Study Formula

Single-Arm Study

Group Type EXPERIMENTAL

Amino Acid-Based Experimental Study Formula

Intervention Type OTHER

Amino Acid-Based Formula; fed ad libitum

Interventions

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Amino Acid-Based Experimental Study Formula

Amino Acid-Based Formula; fed ad libitum

Intervention Type OTHER

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

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No