Phase 2
Completed N=170
Study of Milk Allergy and Tolerance in Children
Food Hypersensitivity · Milk Hypersensitivity
Source: ClinicalTrials.gov NCT00778258 ↗
Enrolled (actual)
170
Serious AEs
1.2%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm — 26; 31 participants — p=0.58
Summary
The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm |
26; 31 | 0.58 |
| SECONDARY Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months |
18; 18; 23; 27 | 0.78 |
| SECONDARY Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months |
29.3; 15.9; 43.9; 29.5; 53.7; 43.2 | 0.14 |
| SECONDARY Percent of Participants Becoming Tolerant to Unheated Cow's Milk |
38.7; 54.5; 53.5 | 0.41 |
| SECONDARY Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity |
41.0; 29.3; 45.6; 20.3; 8.9 | 0.09 |
| SECONDARY Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity |
1.9; 0.6; 1.3; 0.4; 0.2; 12.3 | <0.01 sig |
| SECONDARY Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity |
1160.0; 717.0; 1589.5; 934.0; 524.0; 4.2 | 0.01 sig |
| SECONDARY Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance |
24.0; 17.8; 19.6 | 0.50 |
| SECONDARY Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey |
4.6; 4.6; 5.5; 2.1; 1.6; 7.7 | 0.033 sig |
| SECONDARY Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk |
48.2; 0.0; 0.0 | <0.01 sig |
| SECONDARY Changes in Mechanistic Values [Humoral, T Cell and Basophil] |
— | — |
Eligibility Criteria
Inclusion Criteria
One or more of the following inclusion criteria for enrollment in the study have to be met:
- Convincing history of an allergic reaction to milk or a positive double blind placebo controlled milk challenge (DBPCMC) within the past 2 years and either detectable milk immunoglobulin E (IgE) or positive prick skin test to milk OR
- Serum milk-IgE of high predictive value >14 kUa/L or prick skin test to milk > 10mm wheal within the past 6 months regardless of past clinical history of reactions OR
- Convincing history of an allergic reaction to milk or a positive DBPCMC more than 2 years ago and either a positive serum milk-IgE < 14 kUA/L or positive prick skin test to milk < 10 mm wheal within the past 6 months (eligible only for the active arm of the study and will undergo a reversed sequence of initial baked-milk challenges)
Exclusion Criteria
- Inability or unwillingness of a participant to give written informed consent or to comply with study protocol
Data sourced from ClinicalTrials.gov (NCT00778258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.