Clinical trial NCT06687499: 14-day Susceptibility-guided Bismuth Quadruple Therapy for Multiple Drug Resistant H. Pylori Infection
Official title: The Study of Adding Bismuth on Susceptibility-based Regimen Strategy to Enhance the Eradication Rate for Multi-resistant H. Pylori Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori
Drug Resistance, Multiple
Keywords: bismuth
microbial sensitivity tests
Helicobacter pylori
drug resistance, multiple
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2024-11-13
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if the 14-day susceptibility-guided bismuth quadruple therapy works to treat multiple drug resistant Helicobacter pylori (H. pylori) in adults. It will also learn about the adverse effects of bismuth quadruple therapy. The main questions it aims to answer are:

* Does 14-day susceptibility-guided bismuth quadruple therapy higher the eradication rate?
* What medical problems do participants have when taking 14-day susceptibility-guided bismuth quadruple? Researchers will record 14-day susceptibility-guided bismuth quadruple to see if 14-day susceptibility-guided bismuth quadruple works to treat multiple drug resistant H. pylori.

Participants will:

* Take susceptibility-guided bismuth quadruple every day for 14 days
* Visit the clinic once 4-6 weeks for checkups and tests
* Keep a diary of their symptoms during taking susceptibility-guided bismuth quadruple

Detailed description: Helicobacter pylori (H. pylori) infection is the major culprit of dyspeptic symptoms, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma.

The antibiotic resistance of H. pylori infection is an emerging issue. Moreover, amoxicillin-resistant H. pylori strains increased recently. The amoxicillin resistance rates were 9% in Asia and up to 39% in South America.

Susceptibility-guided therapy is superior to empiric therapy in 2nd-line therapy. After twice eradication failure, H. pylori culture for susceptibility test is strongly recommended, which guide clinician to choose appropriate susceptibility-based therapy. The multiple drug resistant rates may be higher in patients who fail two or more eradication therapy; thus, susceptibility-guided therapy is currently the consensus recommendation for 3rd-line H. pylori eradication. Bismuth quadruple therapy could overcome either clarithromycin or metronidazole resistant strains. Several evidences of clinical randomized-controlled trials demonstrated that adding bismuth as the first line therapeutic regimen can capture additional 30%-40% successful eradication rate for the resistant strain, further contributing to the overall eradication rate.

Accordingly, the aim of our study was to validate the susceptibility-guided bismuth quadruple therapy in patients with multiple drug resistant H. pylori infection in terms of efficacy and side effects.

Eligibility criteria: Inclusion Criteria:

* H. pylori-infected with treatment experience with at least one course of eradication failure
* H. pylori-infected with treatment naïve but having multiple-drug resistant H. pylori (\>= three antibiotics)
* H. pylori infection confirmed by H. pylori culture

Exclusion Criteria:

* Previous allergic reactions to regimens, including amoxicillin, bismuth subcitrate, esomeprazole, metronidazole, rifabutin, and tetracycline,
* Severe comorbidities,
* Chronic kidney disease with estimated glomerular filtration rate \< 60 ml/min/1.73 m2,
* Pregnant or breastfeeding women.
* Dual-resistant H. pylori infection
* Mono-resistant H. pylori infection
* All susceptible H. pylori infection
* Positive RUT but negative H. pylori culture
* Negative RUT and negative H. pylori culture
* Decline to participate

Primary outcomes:
measure: The eradication rate of H. pylori
timeFrame: From enrollment to the end of treatment at 6-8 weeks
Secondary outcomes:
measure: Adverse effects
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Adherence to medications
timeFrame: From enrollment to the end of treatment at 2 weeks
Other outcomes:
measure: The sex-based eradication rate of H. pylori
timeFrame: From enrollment to the end of treatment at 6-8 weeks
measure: The regimen-based eradication rate of H. pylori
timeFrame: From enrollment to the end of treatment at 6-8 weeks
measure: The resistance-number-based eradication rate of H. pylori
timeFrame: From enrollment to the end of treatment at 6-8 weeks
measure: The treatment-failure-experience-based eradication rate of H. pylori
timeFrame: From enrollment to the end of treatment at 6-8 weeks
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Hsiu-Chi Cheng, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Fischbach L, Evans EL. Meta-analysis: the effect of antibiotic resistance status on the efficacy of triple and quadruple first-line therapies for Helicobacter pylori. Aliment Pharmacol Ther. 2007 Aug 1;26(3):343-57. doi: 10.1111/j.1365-2036.2007.03386.x.
citation: Marzio L, Coraggio D, Capodicasa S, Grossi L, Cappello G. Role of the preliminary susceptibility testing for initial and after failed therapy of Helicobacter pylori infection with levofloxacin, amoxicillin, and esomeprazole. Helicobacter. 2006 Aug;11(4):237-42. doi: 10.1111/j.1523-5378.2006.00407.x.
citation: Thung I, Aramin H, Vavinskaya V, Gupta S, Park JY, Crowe SE, Valasek MA. Review article: the global emergence of Helicobacter pylori antibiotic resistance. Aliment Pharmacol Ther. 2016 Feb;43(4):514-33. doi: 10.1111/apt.13497. Epub 2015 Dec 23.