Infants Fed an Amino Acid-based Formula

NCT04127656 | Terminated

• 1 other identifier: AL28
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• Food Allergy Symptom Improvement

  Parent Completed Symptom Diary

  Baseline to Day 28

Secondary Outcomes (4)

• Time to Symptom Resolution or Reduction

  Baseline to Day 28

• Change in Length

  Baseline to Day 28

• Change in Weight

  Baseline to Day 28

• Study Formula Intake

  Baseline to Day 28

Study Arms (1)

Amino Acid-Based Experimental Study Formula

EXPERIMENTAL

Single-Arm Study

Other: Amino Acid-Based Experimental Study Formula

Interventions

Amino Acid-Based Experimental Study Formula OTHER

Amino Acid-Based Formula; fed ad libitum

Amino Acid-Based Experimental Study Formula

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (3)

The Adam Practice

Poole, BH15 4JQ, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Royal London Hospital

Whitechapel, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jan Kajzer, MS, RD, LD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: December 16, 2019
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)