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A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Primary Purpose

Milk Hypersensitivity

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cow's milk powder

Placebo

About this trial

This is an interventional treatment trial for Milk Hypersensitivity focused on measuring Food Allergy, Oral Immunotherapy, Immunoglobulin E

Eligibility Criteria

6 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable
Age 6 to 21 years
Must have history of symptomatic reactivity to cow's milk (eczema, urticaria, upper/lower resp., GI, other associated rash, oral symptoms)
History of positive skin prick test (wheal >/= histamine control) or milk-Immunoglobulin E (IgE)>0.35 kilounits per liter (kU/L)
Positive DBPCFC
All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

History of anaphylaxis requiring hospitalization
History of intubation related to asthma
Has the ability to tolerate >2.4gram of milk protein at initial DBPCFC
Has a history of allergy to any component of vehicle
Pregnancy (need negative test)
Viral upper respiratory infection (URI) or gastroenteritis within 7days of OFC (OFC needs to be rescheduled)
Has pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with moderate persistent asthma
Currently taking greater than medium dose inhaled corticosteroid (>400mcg/day fluticasone or fluticasone equivalent if </=12yo or >600mcg/day if >12 years old)
Antihistamine within 1 week prior to skin testing or food challenges (Skin testing and/or food challenge needs to be rescheduled)
Systemic corticosteroid within 4 weeks prior to baseline visit
Receiving omalizumab, beta-blocker, Angiotensin-converting enzyme (ACE) inhibitor or tricyclic antidepressant therapy
Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
Participation in any interventional study for treatment of a food allergy in the past 12 months
Severe reaction at initial DBPCFC, defined as:
i. Life-threatening anaphylaxis ii. Requires overnight hospitalization

Sites / Locations

The Johns Hopkins Hospital
Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Treatment

Placebo

Arm Description

Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians

Outcomes

Primary Outcome Measures

The Median Milk Threshold Dose Inducing a Reaction

Secondary Outcome Measures

Changes in Cow Milk-IgE

IgE is measured in kilounits per liter (kU/L). Measurements were obtained at Baseline and at 23 weeks

Changes in Cow Milk Immunoglobulin G4 (IgG4)

IgG4 is measured in ug/mL. Measurements were obtained at Baseline and at 23 weeks

Full Information

NCT ID

NCT00465569

First Posted

April 23, 2007

Last Updated

April 18, 2017

Sponsor

Johns Hopkins University

Collaborators

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT00465569

Brief Title

A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

Duke University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.

Detailed Description

This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Bloodwork, skin prick tests (SPTs), pulmonary function tests (PFTs), and oral secretion samples will be done initially and at periodic intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Milk Hypersensitivity

Keywords

Food Allergy, Oral Immunotherapy, Immunoglobulin E

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Treatment

Arm Type

Experimental

Arm Description

Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

cow's milk powder

Intervention Description

Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

The Median Milk Threshold Dose Inducing a Reaction

Time Frame

Baseline and 23 weeks

Secondary Outcome Measure Information:

Title

Changes in Cow Milk-IgE

Description

IgE is measured in kilounits per liter (kU/L). Measurements were obtained at Baseline and at 23 weeks

Time Frame

Baseline and 23 weeks

Title

Changes in Cow Milk Immunoglobulin G4 (IgG4)

Description

IgG4 is measured in ug/mL. Measurements were obtained at Baseline and at 23 weeks

Time Frame

Baseline and 23 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable Age 6 to 21 years Must have history of symptomatic reactivity to cow's milk (eczema, urticaria, upper/lower resp., GI, other associated rash, oral symptoms) History of positive skin prick test (wheal >/= histamine control) or milk-Immunoglobulin E (IgE)>0.35 kilounits per liter (kU/L) Positive DBPCFC All females of child bearing age must be using appropriate birth control Exclusion Criteria: History of anaphylaxis requiring hospitalization History of intubation related to asthma Has the ability to tolerate >2.4gram of milk protein at initial DBPCFC Has a history of allergy to any component of vehicle Pregnancy (need negative test) Viral upper respiratory infection (URI) or gastroenteritis within 7days of OFC (OFC needs to be rescheduled) Has pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with moderate persistent asthma Currently taking greater than medium dose inhaled corticosteroid (>400mcg/day fluticasone or fluticasone equivalent if </=12yo or >600mcg/day if >12 years old) Antihistamine within 1 week prior to skin testing or food challenges (Skin testing and/or food challenge needs to be rescheduled) Systemic corticosteroid within 4 weeks prior to baseline visit Receiving omalizumab, beta-blocker, Angiotensin-converting enzyme (ACE) inhibitor or tricyclic antidepressant therapy Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes) Participation in any interventional study for treatment of a food allergy in the past 12 months Severe reaction at initial DBPCFC, defined as: i. Life-threatening anaphylaxis ii. Requires overnight hospitalization

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert A Wood, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17208602

Citation

Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. doi: 10.1016/j.jaci.2006.09.016. Epub 2006 Oct 27.

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

16275379

Citation

Enrique E, Pineda F, Malek T, Bartra J, Basagana M, Tella R, Castello JV, Alonso R, de Mateo JA, Cerda-Trias T, San Miguel-Moncin Mdel M, Monzon S, Garcia M, Palacios R, Cistero-Bahima A. Sublingual immunotherapy for hazelnut food allergy: a randomized, double-blind, placebo-controlled study with a standardized hazelnut extract. J Allergy Clin Immunol. 2005 Nov;116(5):1073-9. doi: 10.1016/j.jaci.2005.08.027. Epub 2005 Oct 3.

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

result

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A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

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