Esophageal String Test for Helicobacter Pylori

Recruiting in Palo Alto (17 mi)

Overseen byAmy D Klion, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

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. ...

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 am 18 years old or older.

+1 more

Exclusion Criteria

Pregnancy or lactation

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

Inability to swallow pills

+2 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: EnteroTracker(R) ESTExperimental Treatment1 Intervention

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