Esophageal String Test for Helicobacter Pylori

Overseen By Amy D Klion, M.D.

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

Trial Summary

What is the purpose of this trial?

Background: Helicobacter pylori is a bacterium that infects the lining of the stomach and intestines. It can cause peptic ulcers, cancers, and infections. Current methods of diagnosing H. pylori infections have limitations. Researchers want to test a new method of testing for H. pylori. Objective: To compare the esophageal string test (EST) to standard tests for detecting H. pylori infection. Eligibility: People aged 18 years or older with persistent H. pylori infection. Design: Participants will have 3 or 4 clinic visits over 2 to 4 months. Screening visit: Participants will have a physical exam. They will provide a stool sample. Baseline visit: Participants will have blood tests. Then they will have the EST: One end of a string will be taped to the outside of their cheek; the other end will be packed into a capsule. Participants will swallow the capsule, and the string will unwind down their throat into their stomach. The string will be left in for at least 1 hour. Then researchers will gently pull out the string. The fluids soaked into the string will be studied. Some participants will be prescribed antibiotics. Follow-up visit 1: Participants whose H. pylori infection was cured by the antibiotics may leave the study. Those who are still infected will have an endoscopy: A flexible tube will be inserted down the throat and into the stomach. It will take tissue samples from the stomach lining. These participants will then receive antibiotics again. Follow-up visit 2: The physical exam, blood test, and stool sample will be repeated. ...

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 data supports the effectiveness of the Esophageal String Test (EST) treatment for Helicobacter pylori?

The Esophageal String Test (EST) is a minimally invasive method that can effectively collect samples for detecting Helicobacter pylori, showing a sensitivity of 75% and a specificity of 100% in one study. It is simpler and causes less discomfort compared to traditional endoscopy, making it a useful alternative for obtaining bacterial samples for culture and antibiotic susceptibility testing. ^{1 2 3 4 5}

How does the Esophageal String Test for Helicobacter Pylori differ from other treatments?

The Esophageal String Test is unique because it is a non-invasive diagnostic method that involves swallowing a string to collect samples from the esophagus, which can then be analyzed for Helicobacter Pylori, unlike traditional treatments that typically involve medication to eradicate the bacteria. ^{6 7 8 9 10}

Research Team

Amy D Klion, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Validation of the string test for the recovery of Helicobacter pylori from gastric secretions and correlation of its results with urea breath test results, serology, and gastric pH levels. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the string test for the detection of Helicobacter pylori. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Non-endoscopic method to obtain Helicobacter pylori for culture. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of two string tests for obtaining gastric juice for culture, nested-PCR detection, and combined single- and double-stranded conformational polymorphism discrimination of Helicobacter pylori. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Quantitative PCR of string-test collected gastric material: A feasible approach to detect Helicobacter pylori and its resistance against clarithromycin and levofloxacin for susceptibility-guided therapy. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Screening of Swiss Pig Herds for Hepatitis E Virus: A Pilot Study. [2021]

7. France pubmed.ncbi.nlm.nih.gov

[Value of the string test in the diagnosis of duodenal parasitosis]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Hepatitis E virus (87A strain) propagated in A549 cells. [2019]

9. Egypt pubmed.ncbi.nlm.nih.gov

Schistosoma mansoni egg specific antibodies and circulating antigens: assessment of their validity in immunodiagnosis of schistosomiasis. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Hepatitis E virus as a newly identified cause of acute viral hepatitis during human immunodeficiency virus infection. [2022]