Phase 2 N=170 Randomized Treatment

Study of Milk Allergy and Tolerance in Children

Food Hypersensitivity · Milk Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT00778258 ↗

Enrolled (actual)

170

Serious AEs

1.2%

Results posted

Mar 2016

Primary outcome: 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 participants — p=0.58

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Baked Milk (Biological); Non-baked Milk (Biological)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Nov 2014

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]	—	—
SECONDARY Changes in Mechanistic Values [Humoral, T Cell and Basophil]	—	—

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.

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

View full record on ClinicalTrials.gov →

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.