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Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

NCT ID: NCT06731023

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. A subset of individuals, despite undergoing multiple treatment regimens, remain unable to successfully eradicate the infection. The persistence of infection in these cases could be attributed to either the limitations of detection methods leading to false positives or to the infection by superbugs that are highly resistant to antibiotics. This study is designed to ascertain whether these patients are infected with superbugs by employing various diagnostic techniques. Additionally, it aims to assess the antibiotic resistance profiles of strains associated with extremely refractory H. pylori infections through drug susceptibility testing. Based on the identified sensitivities, the study seeks to tailor treatment protocols with bismuth-containing quadruple therapy (Containing two kinds of antibiotics: sensitive antibiotic, rifabutin or high-dose metronidazole), to explore novel therapeutic strategies for patients with highly resistant H. pylori infections.

Detailed Description

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The study enrolled patients with extremely refractory Helicobacter pylori (H. pylori) infection, identified in the outpatient department. Following enrollment, a comprehensive diagnostic approach was employed to ascertain the presence of H. pylori infection and to rule out false positives. Patients who test truly positive for H. pylori should undergo eradication therapy, avoiding any previously administered regimens. For those with unsuccessful culture attempts, a bismuth-containing quadruple therapy (vonoprazan + bismuth + amoxicillin + rifabutin) is recommended as an exploratory approach. Patients with successful cultures should undergo drug susceptibility testing to identify antibiotic resistance patterns of the H. pylori strain. Based on these results, a 14-day course of bismuth-containing quadruple eradication therapy is prescribed. Patients with strains that demonstrate sensitivity to both amoxicillin and rifabutin are assigned to the bismuth-containing quadruple therapy group (vonoprazan + bismuth + amoxicillin + rifabutin). For other patients, two non-resistant antibiotics are selected based on drug susceptibility test outcomes. If a patient shows sensitivity to only one antibiotic, a combination of that sensitive antibiotic with high-dose metronidazole is administered. After eradication treatment, 13C urea breath test and fecal antigen detection were re-examined 4 weeks after drug withdrawal.

Conditions

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HELICOBACTER PYLORI INFECTIONS

Keywords

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Helicobacter pylori Bismuth-Containing Quadruple Therapy Drug Susceptibility Testing

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Unsuccessful culture attempts group

Bismuth-containing quadruple therapy (vonoprazan 20 mg bid + bismuth 0.6g bid + amoxicillin 1g bid + rifabutin 0.15g bid)

Bismuth

Intervention Type DRUG

Bismuth 0.6g bid

Vonoprazan

Intervention Type DRUG

vonoprazan 20mg bid

Amoxicillin

Intervention Type DRUG

Amoxicillin 1g bid

Rifabutin

Intervention Type DRUG

Rifabutin 0.15g bid

Demonstrate sensitivity to both amoxicillin and rifabutin group

Bismuth-containing quadruple therapy (vonoprazan 20 mg bid + bismuth 0.6g bid + amoxicillin 1g bid + rifabutin 0.15g bid)

Bismuth

Intervention Type DRUG

Bismuth 0.6g bid

Vonoprazan

Intervention Type DRUG

vonoprazan 20mg bid

Amoxicillin

Intervention Type DRUG

Amoxicillin 1g bid

Rifabutin

Intervention Type DRUG

Rifabutin 0.15g bid

Drug susceptibility testing group

Two non-resistant antibiotics are selected based on drug susceptibility testing outcomes. If a patient shows sensitivity to only one antibiotic, a combination of that sensitive antibiotic with high-dose metronidazole is administered.

Bismuth

Intervention Type DRUG

Bismuth 0.6g bid

Vonoprazan

Intervention Type DRUG

vonoprazan 20mg bid

Amoxicillin

Intervention Type DRUG

Amoxicillin 1g bid

Rifabutin

Intervention Type DRUG

Rifabutin 0.15g bid

Metronidazole

Intervention Type DRUG

Metronidazole 400mg qid

Other antibiotics

Intervention Type DRUG

The selection of other antibiotics is based on the results of drug susceptibility testing.

Interventions

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Bismuth

Bismuth 0.6g bid

Intervention Type DRUG

Vonoprazan

vonoprazan 20mg bid

Intervention Type DRUG

Amoxicillin

Amoxicillin 1g bid

Intervention Type DRUG

Rifabutin

Rifabutin 0.15g bid

Intervention Type DRUG

Metronidazole

Metronidazole 400mg qid

Intervention Type DRUG

Other antibiotics

The selection of other antibiotics is based on the results of drug susceptibility testing.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18-65.
2. Patients with H.pylori infection (Positive for rapid urease test or 13C urea breath test).
3. Received at least two previous standard treatment protocols for Helicobacter pylori, and the application regimens included at least three low-resistance antibiotics.

Exclusion Criteria

1. Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
2. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
3. Patients with active gastrointestinal bleeding.
4. Patients with a history of upper gastrointestinal surgery.
5. Patients allergic to treatment drugs.
6. Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
8. Patients who are unwilling or incapable to provide informed consents.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiuli Zuo

OTHER

Sponsor Role lead

Responsible Party

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Xiuli Zuo

Professor, Director of gastroenterology department of Qilu hospital.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Xiuli Zuo, MD,PhD

Role: CONTACT

Phone: 15588818685

Email: [email protected]

Facility Contacts

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Xiuli Zuo, MD,PhD

Role: primary

Other Identifiers

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KYLL-202410-006-1

Identifier Type: -

Identifier Source: org_study_id