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New treatment option for Cow's Milk Allergy
Official title Infant Formula in Infants and Children With Cow's Milk Allergy
ClinicalTrials.gov ID: NCT06456541
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 12
You may be able to join if
- 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...
- Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms...
- 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.
You likely can't join if
- 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...
- 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...
- Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Ann Arbor, Michigan, United States; Chapel Hill, North Carolina, United States; Cincinnati, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.