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Trial record 4 of 7 for:    "Cow Milk Allergy" | "Immunoglobulins"

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

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ClinicalTrials.gov Identifier: NCT00465569
Recruitment Status : Completed
First Posted : April 25, 2007
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Milk Hypersensitivity
Interventions Drug: cow's milk powder
Other: Placebo
Enrollment 20
Recruitment Details Children between the ages of 6 and 21 years with a known history of IgE-mediated milk allergy were recruited from the pediatric allergy clinics at the Johns Hopkins University Hospital, Baltimore, Maryland, and Duke University Medical Center, Durham, North Carolina.
Pre-assignment Details Eligibility criteria were a positive skin prick test (SPT) response to milk extract (wheal ≥ histamine control) or milk immunoglobulin E (IgE) level of > 0.35 kilounits per liter (kU/L) and a positive milk challenge result at baseline defined as reacting with clear signs, symptoms, or both to a cumulative dose of 2.5 g or less of milk protein.
Arm/Group Title Active Treatment Placebo
Hide Arm/Group Description

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

cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Pre-measured doses of ProFree, a dry, milk free powder
Period Title: Overall Study
Started 13 7
Completed 12 7
Not Completed 1 0
Reason Not Completed
persistent eczema during dose escalation             1             0
Arm/Group Title Active Treatment Placebo Total
Hide Arm/Group Description

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

cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Placebo Total of all reporting groups
Overall Number of Baseline Participants 13 7 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
<=18 years
13
 100.0%
7
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 7 participants 20 participants
9.3  (3.3) 10.2  (3.3) 9.5  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
Female
5
  38.5%
3
  42.9%
8
  40.0%
Male
8
  61.5%
4
  57.1%
12
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 7 participants 20 participants
13 7 20
History of eczema  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
7
  53.8%
4
  57.1%
11
  55.0%
Current eczema  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
4
  30.8%
2
  28.6%
6
  30.0%
History of asthma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
12
  92.3%
5
  71.4%
17
  85.0%
Current asthma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
9
  69.2%
3
  42.9%
12
  60.0%
History of other food allergy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
10
  76.9%
5
  71.4%
15
  75.0%
1.Primary Outcome
Title The Median Milk Threshold Dose Inducing a Reaction
Hide Description [Not Specified]
Time Frame Baseline and 23 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation. The median milk threshold dose in both groups was 40 with a full range of 40-1340 at the baseline challenge.
Arm/Group Title Active Treatment Placebo
Hide Arm/Group Description:

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

cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Placebo
Overall Number of Participants Analyzed 12 7
Median (Full Range)
Unit of Measure: miligrams
Baseline
40
(40 to 1340)
40
(40 to 1340)
Change at 23 weeks
5100
(2500 to 8100)
0
(-1300 to 0)
2.Secondary Outcome
Title Changes in Cow Milk-IgE
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation
Arm/Group Title Active Treatment Placebo
Hide Arm/Group Description:

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

cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Placebo
Overall Number of Participants Analyzed 12 7
Median (Full Range)
Unit of Measure: percentage of change
8
(-50 to 64)
-5
(-13 to 71)
3.Secondary Outcome
Title Changes in Cow Milk Immunoglobulin G4 (IgG4)
Hide Description IgG4 is measured in ug/mL. Measurements were obtained at Baseline and at 23 weeks
Time Frame Baseline and 23 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the active treatment arm did not complete the study due to persistent eczema during dose escalation
Arm/Group Title Active Treatment Placebo
Hide Arm/Group Description:

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

cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Placebo
Overall Number of Participants Analyzed 12 7
Median (Full Range)
Unit of Measure: percentage of change
767
(29 to 1321)
14
(-14 to 157)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Treatment Placebo
Hide Arm/Group Description Adverse event information is based on percentages of doses. There were 2437 total doses in the active treatment arm with a median of 177 and a range of 155-242 per participant. There was a total of 13 participants in the active treatment arm who were analyzed for the Adverse Events data reported below. Adverse event information is based on percentages of doses. There were 1193 total doses in the placebo arm with a median of 171 and a range of 152-199 per participant. There was a total of 7 participants in the placebo arm who were analyzed for the Adverse Events data reported below.
All-Cause Mortality
Active Treatment Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2437 (0.00%)      0/1193 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active Treatment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2437 (0.00%)      0/1193 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Treatment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1107/2437 (45.42%)      134/1193 (11.23%)    
Gastrointestinal disorders     
Gastrointestinal  458/2437 (18.79%)  458 16/1193 (1.34%)  16
General disorders     
Multiple systems  29/2437 (1.19%)  29 0/1193 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Lower respiratory  198/2437 (8.12%)  198 28/1193 (2.35%)  28
Skin and subcutaneous tissue disorders     
Local symptoms *  870/2437 (35.70%)  870 104/1193 (8.72%)  104
Skin  22/2437 (0.90%)  22 1/1193 (0.08%)  1
Eczema flare  1/2437 (0.04%)  1 1/1193 (0.08%)  1
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Robert A. Wood, MD
Organization: Johns Hopkins University
Phone: 410-955-5883
EMail: rwood@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00465569     History of Changes
Other Study ID Numbers: NA_00002102
First Submitted: April 23, 2007
First Posted: April 25, 2007
Results First Submitted: February 17, 2017
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017