Gastrointestinal STRING Test With Oral Immunotherapy

Food Allergy Clinical Trial

— STRING  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04943744
• Other study ID #: 58997
• Status: Enrolling by invitation
• Start date: May 17, 2021
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 55 Years

Eligibility

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

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Related Conditions & MeSH terms

• Eosinophilia
• Eosinophilic Disorder
• Food Allergy
• Food Hypersensitivity

Intervention

Device:
• Entero-tracker
Esophageal STRING test (Entero-tracker)

Locations

Country	Name	City	State
United States	Sean N Parker Center for Allergy and Asthma Research at Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the proportion of subjects with esophageal eosinophilia (EE)	(defined as an EST score = 2.9) in subjects receiving omalizumab-facilitated mOIT and/or mOIT with concurrent	32 weeks
Secondary	Comparison of EST scores	Comparison of EST scores (composite measure of eosinophilic inflammation) before and after treatment with omalizumab	8 weeks