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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 19 words
    • Site details revised at 5 of 9 sites
  2. Enrollment increased: 61 → 96 participants
    • Eligibility criteria expanded, about 15 words
    v7
  3. Study sites: 8 to 9v6
  4. Study sites: 7 to 8
    • Eligibility criteria expanded, about 1 word
    v5
  5. Study sites: 6 to 7v4
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  1. Eligibility criteria expanded, about 12 wordsv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Jul 2024 to Oct 1, 2024
    • Eligibility criteria revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06456541
Lead Sponsor Abbott Nutrition
Conditions
(from sponsor)		 Cow's Milk Allergy
Related terms Milk Hypersensitivity
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov