Clinical trial NCT04127656: Infants Fed an Amino Acid-based Formula
Official title: Symptom Changes in Infants Fed an Amino Acid-based Formula
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Food Allergy
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-10-15
Enrollment: 26
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Food Allergy Symptom Improvement
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Time to Symptom Resolution or Reduction
timeFrame: Baseline to Day 28
measure: Change in Length
timeFrame: Baseline to Day 28
measure: Change in Weight
timeFrame: Baseline to Day 28
measure: Study Formula Intake
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: The Adam Practice
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Whitechapel
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Abbott Nutrition
name: Jan Kajzer, MS, RD, LD
role: STUDY_CHAIR
References: