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: July 10, 2014
Last verified: July 2014
  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 Objectives

The primary objective is to study the efficacy of milk oral immunotherapy. The secondary objectives are to determine the safety of allergen-specific immunotherapy for milk allergy and whether it will lead to a desensitized or tolerized state. The investigators will also examine if quality of life is improved by expansion of diets and will study the peripheral biomarkers and immune response of children with food allergy.

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
Milk Hypersensitivity
Behavioral: Quality of Life Survey
Dietary Supplement: Milk Oral Immunotherapy
Drug: Milk Protein Powder

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
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:
  • The percentage of children completing desensitization in each study group will be the primary outcome measure. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A secondary outcome measure is the comparison of specific IgE values for milk between the beginning and end of the desensitization protocol. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Another secondary outcome measure includes the comparison of quality of life before and after desensitization. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Another secondary outcome measure includes the comparison of skin prick test for milk extract size before and after desensitization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Another secondary outcome measure includes the percent change in invariant NKT cells and their cytokine expression between the immediate and delayed desensitization groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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 oral Immunotherapy
Subjects will be randomized 1:1 to fall into either Group A, subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder (29 week protocol) or Group B, subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder (42 week protocol). The rationale for establishing these two groups is to compare iNKT cell number and function in children undergoing desensitization versus those intolerant to milk. All patients will complete quality of life survey
Behavioral: Quality of Life Survey

A quality of life questionnaire will be given to the subject and his or her family for voluntary completion. The same questionnaire will be given to the subject and his or her family for voluntary completion at the end of the study.

Through the use of the quality of life questionnaires, we will determine the impact of food allergy on the activities of daily life in food allergic subjects and their families.

Our secondary endpoint in this study evaluates whether there is an impact on the quality of life after completion of the desensitization and introduction of milk into the subject's diet.

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.

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 Measures

The percentage of children completing the desensitization protocol in each study group will be the primary outcome measure. Secondary outcome measures include milk-specific IgE, quality of life before and after desensitization, milk extract skin prick test size, and the percent change in iNKT cells and their cytokine expression between the immediate and delayed desensitization groups.

  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 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 [FEV1 (forced expiratory volume in 1 second) < 60% of predicted, as defined by NHLBI (National Heart, Lung, and Blood Institute) 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, JIPGG, CHOP CTRC
Study First Received: July 13, 2010
Last Updated: July 10, 2014
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:
Food Hypersensitivity
Hypersensitivity
Milk Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014