Health TrialsbyHealthPanel

Infant Formula in Infants and Children With Cow's Milk Allergy

ConditionCow's Milk Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorAbbott Nutrition

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.,

Trial design

Design model

Crossover

Treatments tested in this trial

  • Experimental Extensively Hydrolyzed Formula

    Other intervention

    Experimental powder formula

  • Placebo Extensively Hydrolyzed Formula

    Other intervention

    Placebo powder formula

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Experimental Extensively Hydrolyzed FormulaExperimental treatment 1 intervention
Group B: Placebo Extensively Hydrolyzed FormulaPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Food Challenge Reactions

Percent of positive food challenge reactions to the experimental formula administered to cow's milk allergic infants and children.

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.)

Secondary outcomes

1

Volume of Experimental Formula Intake

Parent completed diaries of Intake

Time frame
Home Feeding Day 1 to Day 7
2

Food Intake during Study

Parent completed daily food diaries

Time frame
Home Feeding Day 1 to Day 7
3

Gastrointestinal Symptoms

Parent completed diaries

Time frame
Home Feeding Day 1 to Day 7
4

Medication Use

Parent completed diaries

Time frame
Home Feeding Day 1 to Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbott Nutrition

Lead sponsor

Source ClinicalTrials.gov
Apply now