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Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 88 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Primary completion date changed from estimate of Jan 30, 2027 to Sep 21, 2026 · Eligibility criteria expanded, about 9 words · Study description revised Show 3 more changesShow less
    • Primary completion date changed from estimate of Jan 30, 2027 to Sep 21, 2026
    • Eligibility criteria expanded, about 9 words
    • Study description revised
  2. Final enrollment: 5 participants (planned 25)v87
  3. Enrollment closed, study ongoingv86
  4. 6 versions Re-verified since Apr 7, 2026, no change to tracked fieldsv80-v85
  5. Primary completion date: Jan 30, 2026 to Jan 30, 2027 Completion date: Mar 30, 2026 to Jan 30, 2027v79 Show 1 more changeShow less
    • Completion date: Mar 30, 2026 to Jan 30, 2027
Show 40 earlier versionsHide 40 earlier versions
  1. Eligibility criteria shortened, about 8 wordsv78 See this version in full on ClinicalTrials.gov ↗
  2. 4 versions Re-verified since Sep 30, 2025, no change to tracked fieldsv74-v77
  3. Study Status, Study Description, Eligibility, Contacts/Locationsv73
  4. Re-verified, no change to tracked fieldsv72
  5. Start date changed from estimate of Jun 30, 2025 to Jun 11, 2025v71
  6. Start date: Jun 29, 2025 to Jun 30, 2025v70
  7. Start date: Jun 26, 2025 to Jun 29, 2025v69
  8. Start date: Jun 24, 2025 to Jun 26, 2025v68
  9. Start date: Jun 23, 2025 to Jun 24, 2025v67
  10. Start date: Jun 20, 2025 to Jun 23, 2025v66
  11. Start date: Jun 19, 2025 to Jun 20, 2025v65
  12. Start date: Jun 18, 2025 to Jun 19, 2025v64
  13. Start date: Jun 17, 2025 to Jun 18, 2025v63
  14. Start date: Jun 16, 2025 to Jun 17, 2025v62
  15. Start date: Jun 15, 2025 to Jun 16, 2025v61
  16. Start date: Jun 12, 2025 to Jun 15, 2025v60
  17. Start date: Jun 11, 2025 to Jun 12, 2025v59
  18. Start date: Jun 10, 2025 to Jun 11, 2025v58
  19. Start date: Jun 9, 2025 to Jun 10, 2025v57
  20. Start date: Jun 8, 2025 to Jun 9, 2025v56
  21. Start date: Jun 5, 2025 to Jun 8, 2025v55
  22. Start date: Jun 3, 2025 to Jun 5, 2025v54
  23. Start date: Jun 2, 2025 to Jun 3, 2025v53
  24. Start date: May 29, 2025 to Jun 2, 2025v52
  25. Start date: May 28, 2025 to May 29, 2025v51
  26. Start date: May 27, 2025 to May 28, 2025v50
  27. Start date: May 26, 2025 to May 27, 2025v49
  28. Start date: May 25, 2025 to May 26, 2025v48
  29. Start date: May 22, 2025 to May 25, 2025v47
  30. Start date: May 21, 2025 to May 22, 2025v46
  31. Start date: May 20, 2025 to May 21, 2025v45
  32. Start date: May 19, 2025 to May 20, 2025v44
  33. Start date: May 16, 2025 to May 19, 2025v43
  34. Start date: May 15, 2025 to May 16, 2025v42
  35. Start date: May 14, 2025 to May 15, 2025v41
  36. Start date: May 13, 2025 to May 14, 2025v40
  37. Start date: May 12, 2025 to May 13, 2025v39
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. ...
Trial Details
NCT Number NCT06871579
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Helicobacter Pylori
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov