Back to results

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

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:

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

Sites / Locations

The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

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

NCT ID

NCT01162473

First Posted

July 13, 2010

Last Updated

May 11, 2015

Sponsor

Children's Hospital of Philadelphia

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

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

Arm Title

Immediate Sensitivity

Arm Type

Active Comparator

Arm Description

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

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

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

Learn more about this trial

Milk Oral Immunotherapy in Children to Treat Food Allergy

We'll reach out to this number within 24 hrs