CClinicalTrials.gg
TerminatedNCT04127656Updated Apr 27, 2022

Infants Fed an Amino Acid-based Formula

An interventional study of Amino Acid-Based Experimental Study Formula in Food Allergy, sponsored by Abbott Nutrition. Terminated at 3 sites in United Kingdom. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2022-04-27.

Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other

Why this study was terminated
Insufficient recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
Up to 12 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Food Allergy

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03

In context

Food Hypersensitivity

340 studies on the registry are indexed under Food Hypersensitivity; 85 are open to participants now.

This study's enrollment of 26 is below the median of 60 across 211 interventional studies indexed under Food Hypersensitivity.

Browse Food Hypersensitivity studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Amino Acid-Based Experimental Study Formula

    Single-Arm Study

    Other: Amino Acid-Based Experimental Study Formula

Interventions

  • OtherAmino Acid-Based Experimental Study Formula

    Amino Acid-Based Formula; fed ad libitum

06

What researchers measure

Primary outcomes

  1. Food Allergy Symptom Improvement

    Parent Completed Symptom Diary

    Time frame: Baseline to Day 28

Secondary outcomes

  1. Time to Symptom Resolution or Reduction

    Parent Completed Symptom Diary

    Time frame: Baseline to Day 28

  2. Change in Length

    Length-for-age z scores

    Time frame: Baseline to Day 28

  3. Change in Weight

    Weight-for-age z scores

    Time frame: Baseline to Day 28

  4. Study Formula Intake

    Parent Completed Intake Diary

    Time frame: Baseline to Day 28

07

Study locations

3 sites
  • The Adam Practice
    Poole, BH15 4JQ, United Kingdom
  • University Hospital Southampton NHS Foundation Trust
    Southampton, SO16 6YD, United Kingdom
  • Royal London Hospital
    Whitechapel, E1 1BB, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04127656
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Oct 15, 2019
Start date
Dec 16, 2019
Primary completion
Dec 16, 2021
Completion
Dec 16, 2021
Last update
Apr 27, 2022

Study contacts

Jan Kajzer, MS, RD, LD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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