Protocol Details
A Pilot Prospective Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
This study is currently recruiting participants.
Summary
Number |
002302-I |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Pregnant Women;
Adults who are or may become unable to consent;
Children;
Fetuses |
Keywords |
Helicobacter Pylori;
Antibiotic resistance;
DIAGNOSTIC TEST |
Recruitment Keyword(s) |
None |
Condition(s) |
Helicobacter Pylori |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Diagnostic Test: EnteroTracker(R) EST
|
Supporting Site |
National Institute of Allergy and Infectious Diseases |
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
INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
-Aged >=18 years
-Diagnosed with H. pylori infection (by endoscopy, stool antigen, or urea breath testing)
-Agreement to adhere to lifestyle considerations throughout study duration
-Ability of participant to provide informed consent
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
-Pregnancy or lactation
-Use of antibiotics with activity against H. pylori within 4 weeks of enrollment
-Anaphylaxis to amoxicillin, tetracycline, clarithromycin, metronidazole, or levofloxacin
-Inability to swallow pills
-Biopsy-proven high grade dysplastic Barrett s esophagus, active peptic ulcer disease, recent (within 4 weeks) upper GI bleed, and/or history of Zollinger Ellison syndrome or gastric bypass surgery
Citations:
Li Y, Lv T, He C, Wang H, Cram DS, Zhou L, Zhang J, Jiang W. Evaluation of multiplex ARMS-PCR for detection of <i>Helicobacter pylori</i> mutations conferring resistance to clarithromycin and levofloxacin. Gut Pathog. 2020 Jul 10;12:35. doi: 10.1186/s13099-020-00373-6. PMID: 32670416; PMCID: PMC7350683.
Han X, Yu X, Gao X, Wang X, Tay CY, Wei X, Lai B, Marshall BJ, Zhang X, Chua EG. 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. Helicobacter. 2023 Aug;28(4):e12985. doi: 10.1111/hel.12985. Epub 2023 Apr 17. PMID: 37066609.
Contacts:
Clinical Trials Number:
NCT06871579