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The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy

This study has been completed.
Sponsor:
Collaborators:
Duke University
Greer Laboratories
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00732654
First received: August 8, 2008
Last updated: April 6, 2017
Last verified: April 2017
Results First Received: March 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Milk Allergy
Interventions: Drug: Milk Protein Extract Immunotherapy goal of 4mg/day
Drug: Milk Protein Extract Immunotherapy goal of 7mg/day
Drug: Milk Powder Immunotherapy goal dose 2000 mg/day
Drug: Milk Powder Immunotherapy goal dose 1000mg/day

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
33 patients underwent screening Double-Blinded Placebo-Controlled Food Challenges (DBPCFCs). Two subjects failed screening because they tolerated at least 2.5g at the initial DBPCFC. One subject declined to continue in the study after the food challenge. 30 subjects were randomized.

Reporting Groups
  Description
SLIT

These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.

Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.

SLIT/OIT B

These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.

Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.

Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

SLIT/ OIT A

These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.

Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.


Participant Flow:   Overall Study
    SLIT   SLIT/OIT B   SLIT/ OIT A
STARTED   10   10   10 
COMPLETED   10   9   10 
NOT COMPLETED   0   1   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
OITA Group

These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.

Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.

Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

OITB Group

These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.

Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.

Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

SLIT Group

These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.

Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.

Total Total of all reporting groups

Baseline Measures
   OITA Group   OITB Group   SLIT Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   10   30 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      10 100.0%      10 100.0%      10 100.0%      30 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3  30.0%      3  30.0%      6  60.0%      12  40.0% 
Male      7  70.0%      7  70.0%      4  40.0%      18  60.0% 
Region of Enrollment 
[Units: Participants]
       
United States   10   10   10   30 
History of anaphylaxis to Cow's Milk (CM) 
[Units: Participants]
Count of Participants
 6   9   8   23 
Other Food Allergies 
[Units: Participants]
Count of Participants
 6   8   9   23 
Asthma 
[Units: Participants]
Count of Participants
 9   9   8   26 
Atopic Dermatitis 
[Units: Participants]
Count of Participants
 6   6   10   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in CM-specific Immunogloblin E (IgE)   [ Time Frame: Change from baseline to after therapy (up to 18 months) ]

2.  Primary:   Change in CM-specific Immunoglobulin G4 (IgG4)   [ Time Frame: Change from baseline to after therapy (up to 18 months) ]

3.  Primary:   Change in End Point Skin Test   [ Time Frame: Change from baseline to after therapy (up to 18 months) ]

4.  Primary:   Oral Food Challenge Threshold (OFC) Threshold   [ Time Frame: Change from baseline to after therapy (up to 18 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Please refer to the links section, it contains a link to the publication of this research study in the Journal of Allergy and Clinical Immunology


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Corinne Keet
Organization: Johns Hopkins University
phone: 4109555883
e-mail: pediatricallergy@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00732654     History of Changes
Other Study ID Numbers: NA_00732654
Study First Received: August 8, 2008
Results First Received: March 28, 2016
Last Updated: April 6, 2017