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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 is a Early Phase 1 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 25 participants.

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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.

Interventions

  • DIETARY_SUPPLEMENT Milk Oral Immunotherapy
  • DRUG Milk Protein Powder
  • OTHER Food Challenge

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2010-06
Est. Completion 2013-12
Phase Early Phase 1

Sponsor

Children's Hospital of Philadelphia

431 total trials

What the Registry Record Tells You About NCT01162473

The ClinicalTrials.gov registry entry for NCT01162473 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Milk Oral Immunotherapy is the first listed.

NCT01162473 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.