drugset / Trial / NCT01750879

Tolerance Following Peanut Oral Immunotherapy

NCT01750879

RandomizedParallel-groupTriple-blindBasic science

Summary

The unifying objective of this project is to determine whether peanut oral immunotherapy (PN OIT) induced clinical tolerance in the context of food allergy is significantly associated with the expansion of a specific regulatory T cell subset (CD45RA- CD25++ FoxP3++) that is thought to be inducible in the gut-associated lymphoid compartment and associated with immunological tolerance. The hypothesis of the study is that the induction of Treg cells will be associated with clinical tolerance. The investigators will measure the change from baseline of induced Treg cells as a frequency of total CD4 T cells during active treatment and compare that between participants who achieve significant clinical tolerance (Tolerance and Partial Tolerance Groups as defined below) and those who do not (Treatment Failure Group).

Timeline

Start
2013-08
Primary completion
2017-07-11
Completion
2017-07-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Peanut Flour Protein / enzyme biologic Oral

Indications