Completed

Furazolidone Quadruple Therapy for Helicobacter Pylori Eradication

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What is being tested

Furazolidone

+ Clarithromycin

Drug
Who is being recruted

From 18 to 70 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorLiaocheng People's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2022

Actual date on which the first participant was enrolled.

This clinical study is focused on finding the best way to treat Helicobacter pylori (H pylori) infection, a common stomach infection. The research involves 500 patients who have not received previous treatment for H pylori and are between the ages of 18 and 70. The goal is to compare the effectiveness and safety of two different medication combinations, one including Furazolidone (FZD) and the other Clarithromycin (CLA), in completely eliminating the infection. The study aims to improve patient outcomes by identifying a more effective treatment option that could potentially lead to better management of H pylori, which is important for preventing related issues such as ulcers and stomach cancer. Participants are randomly placed into two groups, receiving either the FZD or CLA treatment. Each group receives a combination of four medications for 14 days, with specific instructions on when to take each drug in relation to meals. The presence of H pylori after treatment is assessed using various tests at different intervals to ensure accuracy. The study also closely monitors any side effects such as abdominal pain or nausea and evaluates symptom improvement using a rating scale. Additionally, a cost-effectiveness analysis is conducted to determine which treatment provides better results for the cost, which can guide future treatment decisions.

Official TitleEfficacy and Safety of Furazolidone Containing Quadruple Therapy for First-line Helicobacter Pylori Eradication
NCT06823791
Principal SponsorLiaocheng People's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

493 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
H Pylori infection: 13C/14C urea breath test positive or rapid urease test positive or gastric mucosal tissue pathological section HE staining positive or gastric mucosal tissue H. Pylori culture positive or fecal Positive detection of H pylori antigen
No previous History of eradication treatment for H pylori;
Age 18-70 years old;
5 exclusion criteria prevent from participating
Pregnant or lactating women;
There are also other serious diseases that affect the evaluation of this study, such as severe coronary heart disease, liver disease, kidney disease, chronic obstructive pulmonary disease, malignant tumors, and psychological disorders;
Individuals with a history of significant or complex gastrointestinal surgery;
Individuals who are allergic to the drugs used in this study;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients who were enrolled in the experimental group use the furazolidone regimen esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid+ amoxicillin 1000 mg bid+ furazolidone 100 mg bid

Group II

Active Comparator
Patients who were enrolled in the control group use the clarithromycin regimen esomeprazole magnesium 20 mg bid+colloidal bismuth pectin 200mg bid+ amoxicillin 1000 mg bid+ clarithromycin 500 mg bid

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Liaocheng Peoples hospital

Liaocheng, ChinaOpen Liaocheng Peoples hospital in Google Maps
CompletedOne Study Center