Clinical trial NCT04943744: Gastrointestinal STRING Test With Oral Immunotherapy
Official title: Monitoring Gastrointestinal Responses In Food Oral Immunotherapy Using the Esophageal STRING Test
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Eosinophilic Disorder
Food Allergy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 13
Sex: ALL
Minimum age (years): 5
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This STRING companion study will examine markers of esophageal inflammation during the COMBINE study using a minimally-invasive testing device, the esophageal string test (EST). If participants of COMBINE consent to this companion study, they will undergo an esophageal string test at the following time points in COMBINE:

* During screening, prior to week 0, which will be baseline for the STRING esophageal test
* Week 8, After the 8 weeks of treatment with omalizumab/placebo
* If dose-related gastrointestinal (GI) side effects occur during the week 10-32 treatment period (OIT and dupilumab/placebo)
* At Week 32, after 24 weeks of treatment with OIT and dupilumab or placebo
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: This is a companion study to a phase 2 randomized, controlled, double-blind clinical trial using biologics to improve multi-allergen oral immunotherapy (mOIT) outcomes. The parent study (COMBINE NCT03679676) consists of a screening period, 8 weeks of omalizumab or placebo injections, and 24 weeks of OIT with dupilumab or placebo injections followed by an off-treatment period.

This STRING companion study will examine markers of esophageal inflammation during the COMBINE study using a minimally-invasive testing device, the esophageal string test (EST). If participants of COMBINE consent to this companion study, they will undergo an esophageal string test at the following time points in COMBINE:

* During screening, prior to week 0, which will be baseline for the STRING esophageal test
* Week 8, After the 8 weeks of treatment with omalizumab/placebo
* If dose-related gastrointestinal (GI) side effects occur during the week 10-32 treatment period (OIT and dupilumab/placebo)
* At Week 32, after 24 weeks of treatment with OIT and dupilumab or placebo

Eligibility criteria: Inclusion Criteria: • Participants, aged 5-55 years enrolled in the parent COMBINE trial

* Able to swallow the EST.

Exclusion Criteria: • Allergy to, or inability to ingest, gelatin

-

Primary outcomes:
measure: Comparison of the proportion of subjects with esophageal eosinophilia (EE)
timeFrame: 32 weeks
Secondary outcomes:
measure: Comparison of EST scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Sean N Parker Center for Allergy and Asthma Research at Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sharon Chinthrajah, MD
role: PRINCIPAL_INVESTIGATOR
References: