75 Participants Needed

Esophageal String Test for Eosinophilic Esophagitis

SA
Overseen BySharon A Carbonara, MS, BSN, RN
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect Eosinophilic Esophagitis (EoE), a condition that can occur in individuals with food allergies undergoing oral immunotherapy (OIT). It compares the Esophageal String Test (EST), a simple test, to a symptom questionnaire to determine which is more effective at identifying EoE. The trial targets children and teens aged 7 to 18 with a history of food allergies who are considering OIT. Participants must be able to swallow a small capsule for the test. This trial may suit those dealing with food allergies and considering OIT. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future diagnostic methods for EoE.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot have taken oral or intravenous steroids in the last 60 days, except for certain topical ones like fluticasone or budesonide.

What prior data suggests that the Esophageal String Test is safe for screening Eosinophilic Esophagitis?

Research has shown that oral immunotherapy (OIT) can present some safety concerns. Some patients might experience serious allergic reactions requiring treatment with epinephrine. OIT can also increase the risk of developing eosinophilic esophagitis (EoE), which involves inflammation of the esophagus.

In one study, after starting OIT, 45% of patients experienced reduced inflammation, and most saw improvements in their digestive symptoms. However, another study found that patients with certain risk factors might face a higher likelihood of OIT not being effective.

Overall, while many patients tolerate OIT well, some do experience side effects. Participants should be aware of these potential risks and discuss them with their healthcare providers.12345

Why are researchers excited about this trial?

Unlike traditional treatments for eosinophilic esophagitis, which often involve dietary changes, steroids, or proton pump inhibitors, the esophageal string test offers a novel approach to monitoring the condition. This test provides a non-invasive way to assess inflammation in the esophagus, which can help tailor oral immunotherapy more effectively. Researchers are excited because it could lead to more personalized treatment plans and potentially quicker adjustments in therapy, optimizing outcomes for patients.

What evidence suggests that the Esophageal String Test is effective for screening Eosinophilic Esophagitis during oral immunotherapy?

This trial will focus on patients undergoing oral immunotherapy (OIT). Studies have shown that OIT can help people with food allergies by reducing their reactions to allergens. However, OIT may also increase the risk of eosinophilic esophagitis (EoE), a condition where the esophagus becomes inflamed. In this trial, all patients will undergo the Esophageal String Test (EST) to monitor this inflammation. Research has indicated that EST is less invasive and preferred by many over traditional endoscopy. Initial findings suggest that EST can effectively measure esophageal inflammation, making it a useful screening tool during OIT.678910

Who Is on the Research Team?

JM

Jonathan M Spergel, MD, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Inclusion Criteria

I am currently receiving oral immunotherapy for food allergies at CHOP.
I have a history of severe food allergies.
I can and will swallow the esophageal capsule.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Baseline assessment using the Esophageal String Test and PEESS questionnaire before starting OIT

1 week
1 visit (in-person)

Treatment

Participants undergo oral immunotherapy with monitoring using the Esophageal String Test and PEESS at 3 and 6 months

6 months
2 visits (in-person) at 3 and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Esophageal String Test

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patients undergoing oral immunotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

Citations

Esophageal String Test Monitoring to Monitor Eosinophilic ...

The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT ...

Implementation of the esophageal string test in clinical ...

The esophageal string test (EST) is a minimally invasive diagnostic tool used to measure mucosal inflammation without sedation. The test ...

One-Hour Esophageal String Test

Of adult respondents who completed the EST, 92% were willing to repeat the test, and of these, 75% preferred the EST over endoscopy if another evaluation was ...

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 Esophageal String Test as a Diagnostic Screening ...

Eligible participants will be enrolled to assess the performance and accuracy of the 1-hour esophageal string test (EST) as a diagnostic screening tool for ...

A review of the safety of oral immunotherapy in clinical trial ...

Safety concerns are a barrier to oral immunotherapy (OIT). This review aims to describe OIT safety events and explore potential risk factors and mitigating ...

Esophageal String Test Monitoring to Monitor Eosinophilic ...

Patients with IgE mediated food Allergy have elevated risk of eosinophilic esophagitis, and new therapies like oral immunotherapy (OIT) carry additional risk of ...

Ethical Implications of Continuing Oral Immunotherapy ...

After the intervention, 45% of patients had histologic remission and all but one had resolution of gastrointestinal symptoms. The one patient who discontinued ...

Risk Factors and Treatment Outcomes for Oral ...

In long-term follow-up (>3-26 months), 31 of 32 patients were asymptomatic with stable AECs. Patients with OITIGER had a higher OIT failure rate (P = .004) and ...

Risk factors for reactions and adverse effects during oral ...

Oral immunotherapy (OIT) involves the potential for a variety of adverse events, which range from serious systemic reactions that require epinephrine to ...