Evaluation of multiplex ARMS-PCR for detection of Helicobacter pylori mutations conferring resistance to clarithromycin and levofloxacin.
Yangxia Li, Tangshan Lv, Chaochao He...
https://pubmed.ncbi.nlm.nih.gov/32670416Actively Recruiting
Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID06871579
A Pilot Prospective Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-03
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new testing method called the esophageal string test (EST) for detecting Helicobacter pylori infection, a bacterium that infects the stomach and intestines and can cause ulcers and cancers. This study aims to compare the EST to standard tests and assess its ability to detect antibiotic resistance. Adults aged 18 years or older with persistent H. pylori infection are invited to participate. Participants will undergo several visits over 2 to 4 months. During the baseline visit, they will swallow a gelatin-coated capsule containing a string that collects stomach fluids for analysis by PCR to detect H. pylori and resistance genes. Some participants will receive antibiotics according to guidelines. If the infection persists after treatment, they may have an endoscopy with tissue sampling and further antibiotic therapy. Stool antigen tests will be used to check if the infection is cured. Throughout the study, participants will have physical exams, blood tests, stool samples, and the EST procedure. Researchers will monitor the presence of H. pylori and resistance genes using samples from the string and stool. The main measure is the proportion of participants identified as positive for H. pylori by the EST. Safety and treatment response will be followed, with up to four clinic visits including screening, baseline, and follow-ups, lasting about 2 to 4 months.
CONDITIONS
Brief Title
Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged �3e=18 years
- Diagnosed with H. pylori infection by endoscopy, stool antigen, or urea breath testing
- Agreement to follow lifestyle considerations during the study
- Ability to provide informed consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Use of antibiotics active against H. pylori within 4 weeks before enrollment
- Inability to swallow pills
- History of high grade dysplastic Barrett's esophagus, active peptic ulcer disease, recent upper GI bleeding, Zollinger Ellison syndrome, or gastric bypass surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Baseline
Participants undergo an esophageal string test (EST) to detect Helicobacter pylori infection and assess antibiotic resistance genes.
1 visit (in-person)
Treatment
Duration - Variable treatment duration per guidelines
Participants receive antibiotic therapy according to current medical guidelines based on diagnostic results.
Follow-up
Duration - 4 weeks after treatment completion
Participants have a stool antigen test 4 weeks after completing therapy to assess cure. Those with multiple therapy failures may undergo endoscopy with resistance testing and repeat stool antigen testing after additional treatment.
1 to 2 visits depending on therapy response
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
M
Michelle M Luera
A
Amy D Klion, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
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.
Xinyuan Han, Xiqiu Yu, Xiaojuan Gao...
https://pubmed.ncbi.nlm.nih.gov/37066609