Gastrointestinal STRING Test With Oral Immunotherapy

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT04943744
Phase
EARLY_PHASE1
Status
Terminated

Conditions

  • Eosinophilic Disorder
  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
5 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Entero-tracker — DEVICE
    Esophageal STRING test (Entero-tracker)
  • omalizumab — BIOLOGICAL
    Used in the parent study
  • dupliumab — BIOLOGICAL
    Used in the parent study

Study Details

This STRING study will examine markers of esophageal inflammation using a minimally-invasive testing device, the esophageal string test (EST). The primary objective is to determine the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation in the esophagus of subjects treated with omalizumab-facilitated mOIT(mult-allergen oral immunotherapy) and/or mOIT with concurrent dupilumab.

Key Dates

Start date
May 17, 2021
Status verified
Sep 2024
Primary completion
May 17, 2024
Completion
May 17, 2024

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: String Test-cohort A
    Participants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms. A. Omalizumab for 8 weeks followed by mOIT with placebo for dupilumab for 24 weeks (Cohort A: Omalizumab-facilitated mOIT)
  • Other: String Test-cohort B
    Participants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms. B. Omalizumab for 8 weeks followed by mOIT with dupilumab for 24 weeks (Cohort B: Omalizumab-facilitated mOIT with concurrent dupilumab)
  • Other: String Test-cohort C
    Participants in the COMBINE study will have an EST performed at pre- specified timepoints (screening, week 8, and week 32) and as needed depending on GI symptoms. C. Placebo for omalizumab for 8 weeks followed by mOIT with dupilumab for 24 weeks (Cohort C: mOIT with concurrent dupilumab)

Primary Outcome Measure

Comparison of the proportion of subjects with esophageal eosinophilia (EE) [ Time Frame: 32 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sean N Parker Center for Allergy and Asthma Research at Stanford UniversityPalo AltoCalifornia94304-

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Sean N Parker Center for Allergy and Asthma Research at Stanford University· Palo Alto, CA

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