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NCT06456541 · ClinicalTrials.gov registry record · NA
Infant Formula in Infants and Children With Cow's Milk Allergy
A NA study of Cow's Milk Allergy, sponsored by Abbott Nutrition.
- Recruiting
- Registry status
- NA
- Development phase
- 61
- Enrollment target
- 8
- Study locations
NCT06456541: Recruiting NA study of Cow's Milk Allergy, sponsored by Abbott Nutrition.
NCT06456541 is a NA study of Cow's Milk Allergy that is actively recruiting participants, run by Abbott Nutrition. The registered enrollment target is 61 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06456541, a NA study of Cow's Milk Allergy, is actively recruiting participants, sponsored by Abbott Nutrition.
- RECRUITING
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
Percent of positive food challenge reactions to the experimental formula administered to cow's milk allergic infants and children.
Conditions Studied
Interventions
- OTHER Experimental Extensively Hydrolyzed Formula
- OTHER Placebo Extensively Hydrolyzed Formula
Study Locations (8)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
- Nationwide Children's Hospital - Columbus
Colorado
- Children's Hospital Colorado - Aurora
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Michigan
- University of Michigan Food Allergy Clinic - Ann Arbor
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2029-01 |
| Phase | NA |
What NCT06456541 shows while recruiting
NCT06456541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Cow's Milk Allergy appearing as the primary indexed condition, and to 2 interventions - of which Experimental Extensively Hydrolyzed Formula is the first listed.
NCT06456541 lists 8 locations in 6 states (Ohio, Colorado, Illinois).
Frequently Asked Questions
What is clinical trial NCT06456541 about?
NCT06456541 is a clinical study titled "Infant Formula in Infants and Children With Cow's Milk Allergy". 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.
What is the current status of trial NCT06456541?
This trial is currently recruiting. It is a NA study. The enrollment target is 61 participants. The study started on 2024-10-01. Estimated completion is 2029-01.
What conditions does trial NCT06456541 study?
This clinical trial studies the following conditions: Cow's Milk Allergy.
What interventions are being tested in trial NCT06456541?
The interventions under investigation include: Experimental Extensively Hydrolyzed Formula (OTHER), Placebo Extensively Hydrolyzed Formula (OTHER).
Who is sponsoring clinical trial NCT06456541?
This trial is sponsored by Abbott Nutrition, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06456541 being conducted?
This trial has 8 study locations across Colorado, Illinois, Michigan, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06456541's enrollment target sits among peer trials
61 1164th of 2000 higher than 837 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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