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Milk Oral Immunotherapy in Children to Treat Food Allergy

Primary Purpose

Milk Hypersensitivity

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Milk Oral Immunotherapy
Milk Protein Powder
Food Challenge
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Milk Hypersensitivity focused on measuring Food hypersensitivity, Milk hypersensitivity, Milk allergy, Food allergy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Delayed Sensitivity

Immediate Sensitivity

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Subjects Who Completed Desensitization Protocol
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".

Secondary Outcome Measures

Full Information

First Posted
July 13, 2010
Last Updated
May 11, 2015
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT01162473
Brief Title
Milk Oral Immunotherapy in Children to Treat Food Allergy
Official Title
A Study of the Efficacy of Milk Oral Immunotherapy in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Milk Hypersensitivity
Keywords
Food hypersensitivity, Milk hypersensitivity, Milk allergy, Food allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delayed Sensitivity
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Immediate Sensitivity
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk Oral Immunotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Milk Protein Powder
Intervention Description
Milk protein powder will be administered in incremental doses during the desensitization protocol.
Intervention Type
Other
Intervention Name(s)
Food Challenge
Primary Outcome Measure Information:
Title
Number of Subjects Who Completed Desensitization Protocol
Description
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".
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Subjects must be in good health, as determined by medical history and physical examination performed by a study physician. 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. Informed consent of parent or legal guardian is required. Exclusion Criteria: Ability to tolerate eight ounces of cow's milk or eight grams of milk protein powder Pregnancy A history of soy allergy A history of food protein induced enterocolitis syndrome to milk A history of anaphylaxis requiring hospitalization A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management 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 A current diagnosis of severe atopic dermatitis A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease Use of oral or injection steroids within one month of protocol initial visit An acute illness within one week prior to the first dose of oral immunotherapy Use of antihistamines within seven days prior to double blind placebo controlled food challenge (DBPCFC) Use of chronic immunomodulatory therapy Participation in another experimental therapy study Participation in a study for the treatment of food allergy in the past 12 months Inability to discontinue antihistamines for skin testing and food challenges
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan M. Spergel, MD, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonella Cianferoni, MD, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16597075
Citation
Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.
Results Reference
background
PubMed Identifier
18951617
Citation
Skripak JM, Nash SD, Rowley H, Brereton NH, Oh S, Hamilton RG, Matsui EC, Burks AW, Wood RA. A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. J Allergy Clin Immunol. 2008 Dec;122(6):1154-60. doi: 10.1016/j.jaci.2008.09.030. Epub 2008 Oct 25.
Results Reference
background
PubMed Identifier
18158176
Citation
Longo G, Barbi E, Berti I, Meneghetti R, Pittalis A, Ronfani L, Ventura A. Specific oral tolerance induction in children with very severe cow's milk-induced reactions. J Allergy Clin Immunol. 2008 Feb;121(2):343-7. doi: 10.1016/j.jaci.2007.10.029. Epub 2007 Dec 26.
Results Reference
background
PubMed Identifier
15291907
Citation
Meglio P, Bartone E, Plantamura M, Arabito E, Giampietro PG. A protocol for oral desensitization in children with IgE-mediated cow's milk allergy. Allergy. 2004 Sep;59(9):980-7. doi: 10.1111/j.1398-9995.2004.00542.x.
Results Reference
background
PubMed Identifier
18973104
Citation
Zapatero L, Alonso E, Fuentes V, Martinez MI. Oral desensitization in children with cow's milk allergy. J Investig Allergol Clin Immunol. 2008;18(5):389-96.
Results Reference
background

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Milk Oral Immunotherapy in Children to Treat Food Allergy

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