Infants Fed an Amino Acid-based Formula

Not Applicable

Terminated

• Conditions: Food Allergy
• Interventions: Other: Amino Acid-Based Experimental Study Formula

• Registration Number: NCT04127656
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Study Start: 2019-12-16
• Primary Completion: 2021-12-16
• Study Completion: 2021-12-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amino Acid-Based Experimental Study Formula	Amino Acid-Based Experimental Study Formula	Single-Arm Study

Primary Outcome Measures

Name	Time	Method
Food Allergy Symptom Improvement	Baseline to Day 28	Parent Completed Symptom Diary

Secondary Outcome Measures

Name	Time	Method
Time to Symptom Resolution or Reduction	Baseline to Day 28	Parent Completed Symptom Diary
Study Formula Intake	Baseline to Day 28	Parent Completed Intake Diary
Change in Weight	Baseline to Day 28	Weight-for-age z scores
Change in Length	Baseline to Day 28	Length-for-age z scores

Trial Locations

Locations (3)

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, United Kingdom

The Adam Practice; 🇬🇧 Poole, United Kingdom

Royal London Hospital; 🇬🇧 Whitechapel, United Kingdom