Cow's Milk Protein AllergyEAGLENCT02953223
A Study to Monitor the Use of an Amino Acid-Based Infant Formula
An observational study of Cow's Milk Protein Allergy and Eosinophilic Gastrointestinal Disorders, run by Société des Produits Nestlé (SPN) at 29 sites in United States.
Trial summary
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion
- What is being tested?
- Free amino acid infant formula
- How many people
- 144 participants
- Where
- 29 sitesUnited States
- Study dates
- Jan 2017to Jan 2019
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: The intent of the program is to enroll infants consuming a free amino acid based infant formula identified in the US
Who may be able to join
- Infants who use a free amino acid based Infant formula during their first year of life including:
- Those that are currently consuming the formula at the time of enrollment
- Those for whom consumption of the formula is planned
- At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program
Who cannot join
- Infants <37 weeks of corrected gestation age (CGA) at time of enrollment
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
UH Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Pioneer Clinical Research
Coconut Creek, Florida, 33066
Duke University
Durham, North Carolina, 27705
Conduct Clinical Trials
Flushing, New York, 11367
Children's Gastroenterology Speciality
Glenview, Illinois, 60026
The Feinstein Institute for Medical Research
Great Neck, New York, 11021
Cyn3rgy Research
Gresham, Oregon, 97030
Children's Center for GI and Nutrition
Hollywood, Florida, 33021
Childerns Health Center, PA
Homestead, Florida, 33030
Acadiana Pediatric Gastro and Hep
Lafayette, Louisiana, 70508
Pediatric Multicare West
Lakeside, Arizona, 85929
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Childrens Health Center, PA
Marble Falls, Texas, 78654
Tulane University Health Sciences Center
Metairie, Louisiana, 70001
Homestead Medical Clinic
Miami, Florida, 33030
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73104
Springs Medical Research
Owensboro, Kentucky, 42303
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Sutter Institute of Medical Research
Roseville, California, 95816
Southwest Children's Research Assoicaites
San Antonio, Texas, 78229
Dixie Pediatrics
St. George, Utah, 84790
State University of New York (SUNY)
Syracuse, New York, 13210
Multicare Institute for research and Innovation
Tacoma, Washington, 98405
University of Arizona
Tucson, Arizona, 85724
Milestones Pediatric Care
Tulsa, Oklahoma, 74146
Next Phase Research
Virginia Gardens, Florida, 33166
Invocare Clinical Research Center
West Columbia, South Carolina, 29169
Childrens Health Care
Wheeling, Illinois, 60090
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
Read the detailed description
Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula
- Conditions
- Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Short Bowel Syndrome, Multiple Food Allergies
- Being tested
- Free amino acid infant formula
- Medical subject headings
- Milk Hypersensitivity, Eosinophilic Esophagitis, Malabsorption Syndromes, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free amino acid infant formulaOther
Patients who will be fed a free amino acid based infant formula
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula
Measured: 4 months
Secondary outcomes (1)
Clinical characteristics
To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk Protein AllergyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krysmaru AraujoTorres, MD, Study director, Nestle Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953223
- Sponsor's protocol ID
- 15.04.US.HCN
- Acronym
- EAGLE
- Status last verified
- Feb 2020
- First submitted
- 31 Oct 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Monitor the Use of an Amino Acid-Based Infant Formula
- ClinicalTrials.gov ID
- NCT02953223
- Acronym / sponsor ID
- EAGLE / 15.04.US.HCN
- Conditions
- Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Short Bowel Syndrome, Multiple Food Allergies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
Detailed description
Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The intent of the program is to enroll infants consuming a free amino acid based infant formula identified in the US
Key inclusion criteria (4 listed)
- Infants who use a free amino acid based Infant formula during their first year of life including:
- At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program
Key exclusion criteria (1 listed)
- Infants <37 weeks of corrected gestation age (CGA) at time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free amino acid infant formulaPatients who will be fed a free amino acid based infant formula | Other | – |
Primary outcome
Adverse events
Time frame: 4 months
To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula
1 secondary outcome
Clinical characteristics
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krysmaru AraujoTorres, MD study director
Nestle Health Science
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Protein Allergy and Eosinophilic Gastrointestinal Disorders, run by Société des Produits Nestlé (SPN) at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.