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| Name | Class |
|---|---|
| Duke University | OTHER |
| Greer Laboratories | INDUSTRY |
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The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual Immunotherapy (SLIT) | Experimental | 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. |
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| SLIT/ Oral Immunotherpay (OIT) B | Experimental | 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. |
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| SLIT/ OIT A | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk Protein Extract Immunotherapy goal of 4mg/day | Drug | Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in CM-specific Immunogloblin E (IgE) | Cow's milk specific IgE was measured at baseline and after therapy (kUa/L) | Change from baseline to after therapy (up to 18 months) |
| Change in CM-specific Immunoglobulin G4 (IgG4) | Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L) | Change from baseline to after therapy (up to 18 months) |
| Change in End Point Skin Test | Allergen provoked skin test (mm) | Change from baseline to after therapy (up to 18 months) |
| Oral Food Challenge Threshold (OFC) Threshold | mg CM protein | Change from baseline to after therapy (up to 18 months) |
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Inclusion Criteria:
Exclusion Criteria:
Life-threatening anaphylaxis, or Reaction requiring hospitalization
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wood, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Duke University |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Milk Protein Extract Immunotherapy goal of 7mg/day | Drug | Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years. |
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| Milk Powder Immunotherapy goal dose 2000 mg/day | Drug | Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years. |
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| Milk Powder Immunotherapy goal dose 1000mg/day | Drug | Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years. |
|
| Durham |
| North Carolina |
| 27710 |
| United States |
| FG001 |
| 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| History of anaphylaxis to Cow's Milk (CM) | Count of Participants | Participants |
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| Other Food Allergies | Count of Participants | Participants |
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| Asthma | Count of Participants | Participants |
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| Atopic Dermatitis | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in CM-specific Immunogloblin E (IgE) | Cow's milk specific IgE was measured at baseline and after therapy (kUa/L) | Data was not collected for one participant in the SLIT/OIT A group. | Posted | Median | Full Range | kUa/L | Change from baseline to after therapy (up to 18 months) |
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| Primary | Change in CM-specific Immunoglobulin G4 (IgG4) | Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L) | Posted | Median | Full Range | kUa/L | Change from baseline to after therapy (up to 18 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Change in End Point Skin Test | Allergen provoked skin test (mm) | Posted | Median | Full Range | mm | Change from baseline to after therapy (up to 18 months) |
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| Primary | Oral Food Challenge Threshold (OFC) Threshold | mg CM protein | Posted | Median | Full Range | mg | Change from baseline to after therapy (up to 18 months) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 10 | 10 | 10 | ||
| EG001 | 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. | 0 | 10 | 10 | 10 | ||
| EG002 | 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. | 0 | 10 | 10 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal inflammation | Gastrointestinal disorders | Non-systematic Assessment |
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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
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Keet | Johns Hopkins University | 4109555883 | pediatricallergy@jhmi.edu |
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| OG002 | 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 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. Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks. Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years. |
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| OG002 | 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 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. Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks. Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years. |
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| OG002 | 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 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. Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks. Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years. |
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