Clinical Trials

Gastrointestinal STRING Test With Oral Immunotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	5 Years - 55 Years
Gender	All

More Inclusion & Exclusion 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. -

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04943744
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stanford University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sharon Chinthrajah, MD
Principal Investigator Affiliation	Stanford University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Disorder, Food Allergy

Additional Details

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

Arms & Interventions

Arms

: 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.

Interventions

Device: - Entero-tracker

Esophageal STRING test (Entero-tracker)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Palo Alto, California

Status

Address

Sean N Parker Center for Allergy and Asthma Research at Stanford University

Palo Alto, California, 94304

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