Infant Formula for Cow's Milk Allergy

N/A

Recruiting

Research Sponsored by Abbott Nutrition

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 kUA/L or positive skin prick test wheal ≥5 mm;

Participant is between 3 months and 12 years of age at enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.)

Summary

This trial will involve testing a new formula on infants and children who have a confirmed allergy to cow's milk. The trial will be conducted at multiple centers and will involve giving some participants the new formula and

Who is the study for?

This trial is for infants and children between 3 months to 12 years old with a physician-confirmed diagnosis of IgE-mediated cow's milk allergy. They must have specific test results showing this allergy, been on a cow's milk protein-free diet for at least two weeks, and their parents agree to avoid giving them any cow's milk products during the study.

What is being tested?

The trial is testing an experimental extensively hydrolyzed formula against a placebo in kids with cow's milk allergy. It involves a blinded food challenge followed by seven days of feeding the experimental formula to see if it helps without causing allergic reactions.

What are the potential side effects?

Since this is an intervention for allergies, potential side effects may include allergic reactions such as gastrointestinal symptoms, hives, respiratory issues or angioedema similar to those experienced from exposure to allergens.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a milk allergy confirmed by tests.

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I am between 3 months and 12 years old.

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I had an allergic reaction to a food during a doctor-supervised test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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.) for reporting.