Gastrointestinal STRING Test With Oral Immunotherapy

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

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04943744

Acronym

STRING

Enrollment

Registered

2021-06-29

Start date

2021-05-17

Completion date

2024-05-17

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Disorder, Food Allergy

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

Interventions

DEVICEEntero-tracker

Esophageal STRING test (Entero-tracker)

BIOLOGICALomalizumab

Used in the parent study

BIOLOGICALdupliumab

Used in the parent study

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

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

Eligibility

Sex/Gender

ALL

Age

5 Years to 55 Years

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 \-

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Comparison of EST scores	8 weeks	Comparison of EST scores (composite measure of eosinophilic inflammation) before and after treatment with omalizumab

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026