Infants Fed an Amino Acid-based Formula

Food Allergy Clinical Trial

Official title:

Symptom Changes in Infants Fed an Amino Acid-based Formula

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04127656
• Other study ID #: AL28
• Status: Terminated
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: December 16, 2021

Study information

• Verified date: April 2022
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity

Intervention

Other:
• Amino Acid-Based Experimental Study Formula
Amino Acid-Based Formula; fed ad libitum

Locations

Country	Name	City	State
United Kingdom	The Adam Practice	Poole
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	Royal London Hospital	Whitechapel

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Allergy Symptom Improvement	Parent Completed Symptom Diary	Baseline to Day 28
Secondary	Time to Symptom Resolution or Reduction	Parent Completed Symptom Diary	Baseline to Day 28
Secondary	Change in Length	Length-for-age z scores	Baseline to Day 28
Secondary	Change in Weight	Weight-for-age z scores	Baseline to Day 28
Secondary	Study Formula Intake	Parent Completed Intake Diary	Baseline to Day 28