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Infants Fed an Amino Acid-based Formula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04127656
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : October 15, 2019
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Food Allergy Other: Amino Acid-Based Experimental Study Formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Symptom Changes in Infants Fed an Amino Acid-based Formula
Actual Study Start Date : December 16, 2019
Actual Primary Completion Date : December 16, 2021
Actual Study Completion Date : December 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Amino Acid-Based Experimental Study Formula
Single-Arm Study
Other: Amino Acid-Based Experimental Study Formula
Amino Acid-Based Formula; fed ad libitum




Primary Outcome Measures :
  1. Food Allergy Symptom Improvement [ Time Frame: Baseline to Day 28 ]
    Parent Completed Symptom Diary


Secondary Outcome Measures :
  1. Time to Symptom Resolution or Reduction [ Time Frame: Baseline to Day 28 ]
    Parent Completed Symptom Diary

  2. Change in Length [ Time Frame: Baseline to Day 28 ]
    Length-for-age z scores

  3. Change in Weight [ Time Frame: Baseline to Day 28 ]
    Weight-for-age z scores

  4. Study Formula Intake [ Time Frame: Baseline to Day 28 ]
    Parent Completed Intake Diary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127656


Locations
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United Kingdom
The Adam Practice
Poole, United Kingdom, BH15 4JQ
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Royal London Hospital
Whitechapel, United Kingdom, E1 1BB
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Jan Kajzer, MS, RD, LD Abbott Nutrition
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT04127656    
Other Study ID Numbers: AL28
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases