Milk Oral Immunotherapy in Children to Treat Food Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01162473
First received: July 13, 2010
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Milk Hypersensitivity
Dietary Supplement: Milk Oral Immunotherapy
Drug: Milk Protein Powder
Other: Food Challenge
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Efficacy of Milk Oral Immunotherapy in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Number of Subjects Who Completed Desensitization Protocol [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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".


Enrollment: 25
Study Start Date: June 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Delayed Sensitivity
All subjects will undergo a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 16 and continue thru Week 50. Total active participation will last 51 weeks.
Dietary Supplement: Milk Oral Immunotherapy
Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks.
Drug: Milk Protein Powder
Milk protein powder will be administered in incremental doses during the desensitization protocol.
Other: Food Challenge
Active Comparator: Immediate Sensitivity
All subjects will undergo a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 3 and continue thru Week 35. Total active participation will last 38 weeks.
Dietary Supplement: Milk Oral Immunotherapy
Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks.
Drug: Milk Protein Powder
Milk protein powder will be administered in incremental doses during the desensitization protocol.
Other: Food Challenge

Detailed Description:

Primary Study Interventions

Prior to and after the desensitization, we will conduct double-blind placebo controlled food challenges to cow's milk protein. During the desensitization phase, we will give increasing doses of cow's milk protein by mouth on a weekly basis, as tolerated. The desensitization protocol starts with dilutional doses of milk and build up to a goal of 8 ounces of cow's milk.

Main Study Outcome Measure

The percentage of children completing the desensitization protocol in each study group will be the primary outcome measure.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be age six to 17 years and have a history of cow's milk allergy. Subjects shall maintain strict avoidance of consumption of all cow's milk protein containing foods.
  2. Subjects will have a history (within the past six months) of a positive skin prick test to milk extract or an immunocap IgE level greater than 0.35 kilounits per liter (kU/L), and a positive allergic reaction history to milk within the past 12 months.
  3. Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.
  4. Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
  5. Informed consent of parent or legal guardian is required.

Exclusion Criteria:

  1. Ability to tolerate eight ounces of cow's milk or eight grams of milk protein powder
  2. Pregnancy
  3. A history of soy allergy
  4. A history of food protein induced enterocolitis syndrome to milk
  5. A history of anaphylaxis requiring hospitalization
  6. A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management
  7. A current diagnosis of severe persistent asthma [forced expiratory volume in 1 second (FEV1) < 60% of predicted, as defined by National Heart, Lung, and Blood Institute (NHLBI) guidelines, despite current therapy
  8. A current diagnosis of severe atopic dermatitis
  9. A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease
  10. Use of oral or injection steroids within one month of protocol initial visit
  11. An acute illness within one week prior to the first dose of oral immunotherapy
  12. Use of antihistamines within seven days prior to double blind placebo controlled food challenge (DBPCFC)
  13. Use of chronic immunomodulatory therapy
  14. Participation in another experimental therapy study
  15. Participation in a study for the treatment of food allergy in the past 12 months
  16. Inability to discontinue antihistamines for skin testing and food challenges
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162473

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Jonathan M. Spergel, MD, PhD Children's Hospital of Philadelphia
Principal Investigator: Antonella Cianferoni, MD, PhD Children's Hospital of Philadelphia
  More Information

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01162473     History of Changes
Other Study ID Numbers: 09-007320
Study First Received: July 13, 2010
Results First Received: April 22, 2015
Last Updated: May 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Food hypersensitivity
Milk hypersensitivity
Milk allergy
Food allergy

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2015