Cow's Milk AllergyNCT06456541
Infant Formula in Infants and Children With Cow's Milk Allergy
A study testing Experimental Extensively Hydrolyzed Formula in people with Cow's Milk Allergy, run by Abbott Nutrition at 9 sites in United States.
Trial summary
This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- Experimental Extensively Hydrolyzed Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Oct 2024to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
- Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE >0.7 kUᴀ/L or positive skin prick test wheal ≥5 mm;
- Documentation of milk-specific serum IgE ≥15 kUᴀ/L or ≥ 5 kUᴀ/L if younger than 1 year;
- Documented cow's milk skin prick test wheal ≥8mm;
- Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
- Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges.
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- Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment.
- Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
- Participant is between 3 months and 12 years of age at enrollment.
- Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Who cannot join
- Participant is partially or exclusively breastfed at the time of enrollment.
- Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula.
- Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases, or abnormalities other than CMA, immunodeficiencies, unstable asthma, eczema and/or food allergies treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.
- Previous severe anaphylactic reaction to cow's milk within the last two years.,
- An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test.
- Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent.
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- Participant is consuming baked milk products.
- Use of and/or changing dose of high potency steroids.
- Participant is treated with any oral immunotherapy (sublingual, subcutaneous, and epicutaneous) for any food allergy.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
University of Michigan Food Allergy Clinic
Ann Arbor, Michigan, 48106
- Completed
Children's Hospital Colorado
Aurora, Colorado, 80045
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75207
- Recruiting
Phoenix Children's
Phoenix, Arizona, 85016
About this study
Official title: Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.
- Conditions
- Cow's Milk Allergy
- Being tested
- Experimental Extensively Hydrolyzed Formula, Placebo Extensively Hydrolyzed Formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Extensively Hydrolyzed FormulaOther
Experimental powder formula
Placebo Extensively Hydrolyzed FormulaOther
Placebo powder formula
| Study group | Role | What they receive |
|---|---|---|
| Experimental Extensively Hydrolyzed Formula | Experimental | Administered during food challenge and at home feeding period of 7 days Receives: Other: Experimental Extensively Hydrolyzed Formula |
| Placebo Extensively Hydrolyzed Formula | Placebo comparator | Administered during food challenge Receives: Other: Placebo Extensively Hydrolyzed Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Challenge Reactions
Percent of positive food challenge reactions to the experimental formula administered to cow's milk allergic infants and children.
Measured: Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1) (followed by 7 days of feeding the experimental formula at home.)
Secondary outcomes (5)
Volume of Experimental Formula Intake
Parent completed diaries of Intake
Measured: Home Feeding Day 1 to Day 7
Food Intake during Study
Parent completed daily food diaries
Measured: Home Feeding Day 1 to Day 7
Gastrointestinal Symptoms
Parent completed diaries
Measured: Home Feeding Day 1 to Day 7
Medication Use
Parent completed diaries
Measured: Home Feeding Day 1 to Day 7
Food Challenge Positive Reactions
Percent of positive food challenge reactions to the experimental formula
Measured: Home Feeding Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Oct 2024
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk AllergyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456541
- Sponsor's protocol ID
- AL60
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT06456541
- Acronym / sponsor ID
- AL60
- Conditions
- Cow's Milk Allergy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 13 Jun 2024 (actual)
- 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.
This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Extensively Hydrolyzed Formula | Experimental | Other: Experimental Extensively Hydrolyzed FormulaAdministered during food challenge and at home feeding period of 7 days |
| Placebo Extensively Hydrolyzed Formula | Placebo comparator | Other: Placebo Extensively Hydrolyzed FormulaAdministered during food challenge |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Participant's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
- Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges.
- Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment.
- Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
- Participant is between 3 months and 12 years of age at enrollment.
Key exclusion criteria (9 listed)
- Participant is partially or exclusively breastfed at the time of enrollment.
- Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula.
- Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases, or abnormalities other than CMA, immunodeficiencies, unstable asthma, eczema and/or food allergies treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.
- Previous severe anaphylactic reaction to cow's milk within the last two years.,
- An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test.
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 |
|---|---|---|
| Experimental Extensively Hydrolyzed FormulaExperimental powder formula | Other | Experimental Extensively Hydrolyzed Formula |
| Placebo Extensively Hydrolyzed FormulaPlacebo powder formula | Other | Placebo Extensively Hydrolyzed Formula |
Primary outcome
Food Challenge Reactions
Time frame: Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1) (followed by 7 days of feeding the experimental formula at home.)
Percent of positive food challenge reactions to the experimental formula administered to cow's milk allergic infants and children.
5 secondary outcomes
Volume of Experimental Formula Intake
Time frame: Home Feeding Day 1 to Day 7
Food Intake during Study
Time frame: Home Feeding Day 1 to Day 7
Gastrointestinal Symptoms
Time frame: Home Feeding Day 1 to Day 7
Medication Use
Time frame: Home Feeding Day 1 to Day 7
Food Challenge Positive Reactions
Time frame: Home Feeding Day 1 to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Extensively Hydrolyzed Formula in people with Cow's Milk Allergy, run by Abbott Nutrition at 9 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen DeLuca (6145653522, kristen.deluca@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Challenge Reactions (time frame: Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1) (followed by 7 days of feeding the experimental formula at home.)). 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 15 Oct 2026.