Cow's Milk AllergyNCT04910373
Extensively Hydrolyzed 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 4 sites in United States.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled food challenge to be conducted in infants or 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
- 1 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Jan 2022to 18 Feb 2022
- Phase
- Interventional
- 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 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant has a physician diagnosis of IgE-mediated Cow's Milk Allergy (CMA) based on a clinical history of a reaction resulting in characteristic immediate hypersensitivity symptoms within 2 hours of oral exposure or immediate hypersensitivity symptoms according to physician's observation
- Participant is willing to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
- Documentation of milk-specific serum IgE >15 kIUA/L or > 5 kIUA/L if younger than 1 year.
- Documented cow's milk skin prick test mean wheal >10mm
- Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
- Participant agrees to stop oral steroid use within 14 days and antihistamine use within 7 days of confirmation of diagnosis and food challenges.
Show all 9Show fewer
- Participant had followed a strict cow's milk protein-free diet prior to enrollment.
- Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
- 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 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, asthma 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.
- Participant is routinely consuming baked milk products.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Children's Hospital Colorado
Aurora, Colorado, 80045
UNC-Chapel Hill
Chapel Hill, North Carolina, 27599
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
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-blind, placebo-controlled food challenge to be conducted in infants or 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 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 Positive Reactions
Percent of positive food challenge reactions to the experimental formula
Measured: Food Challenge Day 1 to Food Challenge Day 2
Secondary outcomes (5)
Experimental Formula Intake
Parent completed diaries of formula intake
Measured: Home Feeding Day 1 to Day 7
Food Intake
Parent completed 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 posted2 Jun 2021
- Study start25 Jan 2022
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Why it stopped: Product Availability Due to Recall
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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlett Ramirez, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910373
- Sponsor's protocol ID
- AL36
- Status last verified
- Jun 2022
- First submitted
- 18 May 2021
- Last updated
- 5 Jul 2022
- 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 5 Jul 2022. 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
- NCT04910373
- Acronym / sponsor ID
- AL36
- Conditions
- Cow's Milk Allergy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product Availability Due to Recall
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 2 Jun 2021 (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-blind, placebo-controlled food challenge to be conducted in infants or 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 |
| 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 (9 listed)
- Participant has a physician diagnosis of IgE-mediated Cow's Milk Allergy (CMA) based on a clinical history of a reaction resulting in characteristic immediate hypersensitivity symptoms within 2 hours of oral exposure or immediate hypersensitivity symptoms according to physician's observation
- Participant is willing to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
- Participant agrees to stop oral steroid use within 14 days and antihistamine use within 7 days of confirmation of diagnosis and food challenges.
- Participant had followed a strict cow's milk protein-free diet prior to enrollment.
- Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
Key exclusion criteria (7 listed)
- Participant is 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, asthma 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 Positive Reactions
Time frame: Food Challenge Day 1 to Food Challenge Day 2
Percent of positive food challenge reactions to the experimental formula
5 secondary outcomes
Experimental Formula Intake
Time frame: Home Feeding Day 1 to Day 7
Food Intake
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
The study was stopped early (reason given: Product Availability Due to Recall). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- 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.
Carlett Ramirez study chair
Abbott Nutrition
4 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 4 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study was stopped early (reason given: Product Availability Due to Recall). Results are not available in the source record.
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?
Food Challenge Positive Reactions (time frame: Food Challenge Day 1 to Food Challenge Day 2). 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 5 Jul 2022.