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NCT01162473 · ClinicalTrials.gov registry record · Early Phase 1
Milk Oral Immunotherapy in Children to Treat Food Allergy
A Early Phase 1 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
NCT01162473: Completed Early Phase 1 study, sponsored by Children's Hospital of Philadelphia.
NCT01162473 is a Early Phase 1 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 25 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01162473, a Early Phase 1 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Background and Rationale For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy. Main Objective The primary objective is to study the efficacy of milk oral immunotherapy. Target Population Children aged six to 17 years with a history of cow's milk allergy will be recruited from The Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.
Primary Outcome
Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be "treatment failures". Subjects who completed the desensitization protocol were considered to be "treatment successes".
Interventions
- DIETARY_SUPPLEMENT Milk Oral Immunotherapy
- DRUG Milk Protein Powder
- OTHER Food Challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-12 |
| Phase | Early Phase 1 |
What the finished NCT01162473 record still lists
NCT01162473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Milk Oral Immunotherapy is the first listed.
NCT01162473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01162473 about?
NCT01162473 is a clinical study titled "Milk Oral Immunotherapy in Children to Treat Food Allergy". Background and Rationale For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Given th...
What is the current status of trial NCT01162473?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2010-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01162473?
The interventions under investigation include: Milk Oral Immunotherapy (DIETARY_SUPPLEMENT), Milk Protein Powder (DRUG), Food Challenge (OTHER).
Who is sponsoring clinical trial NCT01162473?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01162473's enrollment target sits among peer trials
25 1000th of 2000 higher than 965 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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