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Oral Immunotherapy for Peanut Allergy (PMIT) (PMIT)

This study has been completed.
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00597675
First received: January 4, 2008
Last updated: March 22, 2017
Last verified: March 2017
Results First Received: January 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Food Hypersensitivity
Interventions: Biological: Peanut OIT
Biological: Placebo

  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
No text entered.

Reporting Groups
  Description
Placebo Oat flour taken daily as a placebo
Peanut OIT Peanut flour ingested daily as active OIT treatment

Participant Flow for 2 periods

Period 1:   Blinded Phase
    Placebo   Peanut OIT
STARTED   4   6 
COMPLETED   2   5 
NOT COMPLETED   2   1 

Period 2:   Open Label Phase
    Placebo   Peanut OIT
STARTED   2 [1]   5 
COMPLETED   2   5 
NOT COMPLETED   0   0 
[1] Patients previously on placebo were crossed over onto open label peanut OIT



  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.
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Reporting Groups
  Description
Placebo Oat flour taken daily as a placebo
Peanut OIT Peanut flour ingested daily as active OIT treatment
Total Total of all reporting groups

Baseline Measures
   Placebo   Peanut OIT   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   6   10 
Age 
[Units: Years]
Mean (Full Range)
 5.8 
 (4.8 to 6.9) 
 5.2 
 (3.6 to 7.0) 
 5.4 
 (3.6 to 7.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      3  50.0%      3  30.0% 
Male      4 100.0%      3  50.0%      7  70.0% 
Region of Enrollment 
[Units: Participants]
     
United States   4   6   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT.   [ Time Frame: 36-60 months ]

2.  Secondary:   The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment.   [ Time Frame: 12 months ]

3.  Secondary:   The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing   [ Time Frame: Baseline to end of open label phase treatment (36-60 months) ]

4.  Secondary:   The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood   [ Time Frame: Baseline to end of open label phase treatment (36-60 months) ]

5.  Secondary:   The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood.   [ Time Frame: Baseline to end of open label phase treatment (36-60 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Edwin Kim, Director of the UNC Food Allergy Initiative
Organization: University of North Carolina at Chapel Hill
phone: 919-843-9087
e-mail: edwinkim@email.unc.edu



Responsible Party: Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00597675     History of Changes
Other Study ID Numbers: Pro00000163
Study First Received: January 4, 2008
Results First Received: January 25, 2017
Last Updated: March 22, 2017