Esophageal String Test for Helicobacter Pylori

Overseen By Michelle M Luera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Anaphylaxis, Dysplastic Barrett's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to detect Helicobacter pylori (H. pylori), a bacterium that can cause stomach issues such as ulcers and infections. The goal is to determine if the esophageal string test (EST) matches or surpasses current testing methods. Individuals with a persistent H. pylori infection who can adhere to study guidelines may be suitable candidates for this trial.

As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future diagnostic methods.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used antibiotics that work against H. pylori within 4 weeks of joining the study.

What prior data suggests that the esophageal string test is safe for detecting H. pylori?

Research has shown that the Esophageal String Test (EST) is a simple and less invasive method for various medical purposes. For instance, other studies have used it to check for inflammation in the esophagus, and people generally tolerate it well.

No reports of serious side effects have emerged from using the EST to test for Helicobacter pylori (H. pylori), the bacteria that cause stomach problems. The test involves swallowing a capsule with an attached string, which collects samples from the stomach for analysis. This method is less invasive than procedures like endoscopies, which require inserting a tube into the stomach.

Since the trial remains in the early stages without a specific "phase" label, it primarily compares this test to other methods. While the safety profile is still being confirmed, existing studies suggest it is safe for humans. Participants can expect a simple process with minimal discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Esophageal String Test (EST) is unique because it uses a novel delivery method involving a gelatin-coated capsule with a collection string, allowing for a non-invasive way to sample the stomach lining. Unlike traditional methods like endoscopy, which can be uncomfortable and invasive, EST aims to simplify the diagnosis process for Helicobacter pylori infections. Researchers are excited about this test because it could make diagnosing H. pylori more accessible and comfortable for patients, potentially leading to earlier detection and treatment.

What evidence suggests that the esophageal string test is effective for detecting H. pylori infection?

Research has shown that the Esophageal String Test (EST), which participants in this trial will undergo, offers a new method to detect Helicobacter pylori, a germ linked to ulcers and stomach cancer. Early results suggest that although the EST is less invasive than an endoscopy, it might not detect all infections, potentially missing some cases compared to the traditional method. However, EST could provide a simpler and more comfortable option for patients. The test involves swallowing a string to collect stomach fluids, which are then checked for H. pylori. ^{1 2 4 6 7}

Who Is on the Research Team?

Amy D Klion, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

This trial is for adults over 18 with persistent Helicobacter pylori infection, which can cause stomach issues and ulcers. Participants will undergo several clinic visits, including physical exams and providing stool samples.

Inclusion Criteria

Agreement to adhere to lifestyle considerations throughout study duration

Ability of participant to provide informed consent

I still have H. pylori infection after treatment.

Exclusion Criteria

Pregnancy or lactation

Anaphylaxis to amoxicillin, tetracycline, clarithromycin, metronidazole, or levofloxacin

Inability to swallow pills

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants will have blood tests and undergo the esophageal string test (EST) for H. pylori detection

1 day

1 visit (in-person)

Follow-up

Participants whose H. pylori infection was cured may leave the study. Those still infected will have an endoscopy and receive antibiotics again

4 weeks

2 visits (in-person)

Follow-up 2

Physical exam, blood test, and stool sample will be repeated to assess cure

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Esophageal String Test (EST)

Trial Overview The study is testing the Esophageal String Test (EST) against standard methods for detecting H. pylori. It involves swallowing a capsule attached to a string that collects stomach fluids for analysis.

How Is the Trial Designed?

Group I: EnteroTracker(R) EST Experimental Treatment 1 Intervention

Esophageal string test device consists of a gelatin-coated capsule with a collection string wrapped inside.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06871579

NCT06871579 | Study of the Esophageal String Test (EST) ... Study Description: Adults with active Helicobacter pylori infection will undergo an esophageal string test (EST). The gastric portion of the string will be used ...

2. trialx.com trialx.com/clinical-trials/listings/296799/study-of-the-esophageal-string-test-est-for-the-diagnosis-of-helicobacter-pylori/

Study of the Esophageal String Test (EST) for ... Adults with active Helicobacter pylori infection and a history of treatment failure will undergo an esophageal string test (EST). The gastric ...

3. withpower.com withpower.com/trial/phase-helicobacter-pylori-2-2025-6fa15

Esophageal String Test for Helicobacter Pylori What data supports the effectiveness of the Esophageal String Test (EST) treatment for Helicobacter pylori? The Esophageal String Test (EST) is a minimally ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4611335/

Evaluation of the string test for the detection of Helicobacter ... The string test is an alternative method to endoscopy in obtaining H. pylori but has a low sensitivity compared to endoscopic biopsies.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07027826?utm_source=trialradar

The Esophageal String Test as a Diagnostic Screening ... To test if the EST can diagnose EoE in people who have trouble swallowing. Eligibility: Adults aged 18 to 65 years with trouble swallowing. They must have been ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9035192/

Non-Invasive Tests for Eosinophilic Esophagitis This study provided the proof of concept that an esophageal string could be utilized to measure the degree of eosinophilic inflammation in EoE. Based on these ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120621011753

Noninvasive tests for eosinophilic esophagitis In this review, we will summarize the existing literature for several promising minimally invasive tests to measure disease activity in EoE.