Gastrointestinal STRING Test With Oral Immunotherapy

Sponsor

Stanford University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04943744

Collaborator

(none)

Enrollment

Location

19.5

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Disorder Food Allergy	Device: Entero-tracker

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Monitoring Gastrointestinal Responses In Food Oral Immunotherapy Using the Esophageal STRING Test

Actual Study Start Date :

May 17, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
String Test 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.	Device: Entero-tracker Esophageal STRING test (Entero-tracker)

Arm

Intervention/Treatment

String Test

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.

Device: Entero-tracker

Esophageal STRING test (Entero-tracker)

Outcome Measures

Primary Outcome Measures

Comparison of the proportion of subjects with esophageal eosinophilia (EE) [32 weeks]
(defined as an EST score ≥ 2.9) in subjects receiving omalizumab-facilitated mOIT and/or mOIT with concurrent

Secondary Outcome Measures

Comparison of EST scores [8 weeks]
Comparison of EST scores (composite measure of eosinophilic inflammation) before and after treatment with omalizumab

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sean N Parker Center for Allergy and Asthma Research at Stanford University	Mountain View	California	United States	94040

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Sharon Chinthrajah, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

R. Sharon Chinthrajah, Medical Director, Clinical Research Uni, Stanford University

ClinicalTrials.gov Identifier:

NCT04943744

Other Study ID Numbers:

58997

First Posted:

Jun 29, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Eosinophilia

Food Hypersensitivity

Study Results

No Results Posted as of Sep 5, 2021