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

Conditions

• Cow's Milk Allergy

Eligibility Criteria

Sex

ALL

Age

3 Months - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Experimental Extensively Hydrolyzed Formula — OTHER
  Experimental powder formula
• Placebo Extensively Hydrolyzed Formula — OTHER
  Placebo powder formula

Study Details

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.

Key Dates

Start date

Oct 1, 2024

Status verified

May 2026

Primary completion

Jul 31, 2028

Completion

Jan 31, 2029

Study Design

Enrollment

61 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• Experimental: Experimental Extensively Hydrolyzed Formula
  Administered during food challenge and at home feeding period of 7 days
• Placebo Comparator: Placebo Extensively Hydrolyzed Formula
  Administered during food challenge

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.) ]

Central Contacts

• Kristen DeLuca
  6145653522
  [email protected]
• Jane Schlezinger
  +44 (0) 1628 77355
  [email protected]

Locations (9)

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