Viewing Study NCT04107194



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Last Modification Date: 2024-10-26 @ 1:19 PM
Study NCT ID: NCT04107194
Status: UNKNOWN
Last Update Posted: 2021-01-12
First Post: 2019-09-25

Brief Title: Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection
Sponsor: University of Bari
Organization: University of Bari

Study Overview

Official Title: Comparison Between Tailored Therapy Guided by a Non-invasive Antibiotic Susceptibility Test and Empiric Treatment for First-line Helicobacter Pylori Eradication in Patients With Dyspepsia a Randomized Controlled Trial
Status: UNKNOWN
Status Verified Date: 2021-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: THD-HP
Brief Summary: The aim of our study will be to assess in an open-label multicenter randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen For this purpose consecutive patients with dyspeptic symptoms diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms
Detailed Description: Study design

Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis ie histology rapid urease test urea breath test and serology Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment using real time-polymerase chain reaction RT-PCR to detect bacterial DNA mutations conferring resistance to amoxicillin clarithromycin tetracycline metronidazole and levofloxacin Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen according to the 2017 European Helicobacter pylori management guidelines In all participants infection eradication will be evaluated 30 days after treatment end using urea breath test We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances using the RT-PCR on gastric biopsy specimens as the reference standard

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None