Infants Fed an Amino Acid-based Formula

Symptom Changes in Infants Fed an Amino Acid-based Formula

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

Study Overview

• Status: Terminated
• Conditions: Food Allergy
• Intervention / Treatment: Other: Amino Acid-Based Experimental Study Formula

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Poole, United Kingdom, BH15 4JQ
    • The Adam Practice
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust
  • Whitechapel, United Kingdom, E1 1BB
    • Royal London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jan Kajzer, MS, RD, LD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): December 16, 2021
• Study Completion (Actual): December 16, 2021

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: AL28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No