Furazolidone Quadruple Regimen Eradicate H. Pylori Infection

NCT06823791 | Completed Phase 1 DMC

• 1 other identifier: 1234567
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 1

Brief Summary

Research protocol: Experimental group: First line solution (furazolidone regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + furazolidone 100 mg, twice daily, for 14 days. Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days. Control group: First line solution (clarithromycin regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + clarithromycin 500 mg, twice a day, for 14 days. Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days. Main study endpoint: The difference in the eradication rate of H. pylori infection between the furazolidone quadruple regimen and the clarithromycin quadruple regimen. Secondary study endpoint:

1. 1.Safety and compliance of the furazolidone quadruple regimen.
2. 2.Comparison of high-dose dual therapy with furazolidone quadruple therapy and clarithromycin quadruple therapy on H. pylori eradication rate.
3. 3.1-year recurrence and recurrence rate of H. pylori infection.

Conditions

Helicobacter Pylori Infection; Eradication

Keywords

H. pylori eradication; furazolidone quadruple regimen; clarithromycin quadruple regimen

Outcome Measures

Primary Outcomes (1)

• Hp eradication rate

  The status of Hp infection was determined by methods as follows: 1. 13C/14C urea breath test (UBT) 2. rapid urease test (RUT) 3. HE staining of gastric mucosal histopathological sections 4. gastric mucosal Hp culture 5. fecal Hp antigen test. Post-treatment Hp status was assessed 4 weeks after finishing the treatment. Hp was considered eradicated if post-treatment Hp was negative. If the result was positive, it was retested again after half a year. If the retested result was still positive, Hp eradication failed.

  6 months

Secondary Outcomes (1)

• adverse reactions

  1 month

Study Arms (2)

furazolidone regimen

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

Drug: Furazolidone

Clarithromycin regimen

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

Drug: Clarithromycin

Interventions

Furazolidone DRUG

esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + furazolidone 100 mg bid, for 14 days. After stopping the medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months and 12 months, the experiment stop. If H. pylori is positive, check again after 6 months. If H. pylori is still positive, high-dose dual therapy will be used to resist H. pylori again. After stopping the second medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months, and the experiment stops. If H. pylori is still positive, check again after 6 months, and the experiment stops.

Also known as: esomeprazole magnesium, colloidal bismuth pectin, amoxicillin

furazolidone regimen

Clarithromycin DRUG

esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + clarithromycin 500 mg bid, for 14 days. After stopping the medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months and 12 months, the experiment stop. If H. pylori is positive, check again after 6 months. If H. pylori is still positive, high-dose dual therapy will be used to resist H. pylori again. After stopping the second medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months, and the experiment stops. If H. pylori is still positive, check again after 6 months, and the experiment stops.

Also known as: esomeprazole magnesium, colloidal bismuth pectin, amoxicillin

Clarithromycin regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Unable to cooperate with this experimenter.

Sponsors & Collaborators

• Liaocheng People's Hospital: lead

Study Sites (1)

Liaocheng Peoples hospital

Liaocheng, Shandong, 252000, China

Location

MeSH Terms

Interventions

Furazolidone; Esomeprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Furans; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Lifeng Liu

  Liaocheng Peoples hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy chief doctor

Model Details: A total of 500 patients with primary H pylori infection were collected from Liaocheng People's Hospital. Patients were randomly divided into FZD group and CLA group.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: February 12, 2025
• Study Start: August 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)