NCT02894268

Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy

Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.

Detailed description

This study is a prospective, multiple centers, randomized trial. Patients who had failed in previous H. pylori eradication treatment that more than two times will be enrolled in Sir Run Run Shaw Hospital. Pretreatment H. pylori status will be defined by a positive 13 C-urea breath test (13 C-UBT). Patients who had received bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before 13 C-UBT are excluded. Other exclusion criteria included upper gastrointestinal surgery, malignancy, and evidence of blood dyscrasia. After the patient is enrolled the patient will sign the informed consent and receive gastroscopy. More than four biopsy will be given including two in antrum and two in gastric body. One pair of biopsy sample will be sent for the pathology and the other pair is used for H.pylori culture and antibiotics sensitivity. After we get the result of antibiotics sensitivity the patient will be divided randomly into two groups, Regimen A, Regimen B. The Regimen A includes esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg . All drugs are taken twice a day for 14 days. The Regimen B includes two antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg. The esomeprazole and bismuth are taken half an hour before a meal and antibiotics after the meal. All patients are asked to quit smoking and drinking and forbid eating foods rich in tyramine (e.g., chicken, cheese, pickles, lentils, beans) and seafood during and in 1 week after the treatment. Patients will be followed up at the 1st day, 14th day, and 4 weeks after the treatment, respectively, and all side effects will be collected.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Doxycycline	Doxycycline 100g po bid
DRUG	Furazolidone	Furazolidone 100mg po bid
DRUG	Esomeprazole	Esomeprazole 20mg po bid
DRUG	Colloidal Bismuth Subcitrate	Bismuth 20mg po bid
DRUG	Sensitivity antibiotics	Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-10-01
• Completion: 2019-12-01
• First posted: 2016-09-09
• Last updated: 2018-09-05

Locations

1 site across 1 country: China