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Food Allergen OIT for Shrimp and Cashew

NCT03504774 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-04-27

Study results available
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Summary

A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).

Conditions

  • Allergy;Food
  • Allergy to Shrimp
  • Allergy to Cashew Nut (Disorder)

Interventions

DRUG

Cashew or Shrimp Oral Immunotherapy

All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Sayantani B. Sindher

    lead OTHER

Principal Investigators

  • Sayantani Sindher, MD · Stanford University, SNP Center for Food Allergy and Asthma Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2023-01-13
Completion
2023-03-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504774 on ClinicalTrials.gov