Baked Milk Oral Immunotherapy for Cow's Milk Allergy
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|ClinicalTrials.gov Identifier: NCT03462030|
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2018
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cow's Milk Allergy||Drug: Baked non-fat cow's milk powder Drug: Placebo: Tapioca Powder||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Placebo controlled|
|Official Title:||Phase I Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2022|
Experimental: Baked Milk Immunotherapy
Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.
Drug: Baked non-fat cow's milk powder
Oral immunotherapy with increasing quantities of baked milk.
Other Name: Investigational New Drug (IND) 17114
Placebo Comparator: Placebo
Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.
Drug: Placebo: Tapioca Powder
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: End of year 1 ]Adverse events will be recorded per CTCAE version 4.0. Events per dose on baked milk oral immunotherapy will be compared to adverse events per dose on placebo. Data will be collected over the first year of treatment. Analysis of cumulative adverse reactions per dose of oral immunotherapy or placebo will be performed at the end of year 1.
- Change in the proportion of subjects who are able to tolerate 4 grams of baked milk protein after one and two years of treatment [ Time Frame: End of study year 1 and the end of study year 2 ]The investigators will perform baked milk challenges to 4044 mg of baked milk protein and calculate the proportion of subjects who tolerate 4 grams of unheated milk protein after one and two years of baked milk oral immunotherapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462030
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Robert Wood, MD||Johns Hopkins University|