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

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Colloidal Bismuth Subcitrate; Drug: Esomeprazole; Drug: Furazolidone; Drug: Sensitivity antibiotics; Drug: Doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT02894268

20160513-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A positive 13 C-urea breath test
2. Formal H.pylori treatment more than two times
3. Age >18 years

Exclusion criteria

1. Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled
2. Allergic to the medications
3. Upper gastrointestinal surgery history
4. Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems
5. Evidence of blood dyscrasia
6. Pregnant and lactating women
7. Can't express his complain correctly and can't cooperate with the researcher

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Regimen A

Experimental group

Description:

esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg

Treatment:

Drug: Doxycycline

Drug: Esomeprazole

Drug: Furazolidone

Drug: Colloidal Bismuth Subcitrate

Regimen B

Active Comparator group

Description:

two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg

Treatment:

Drug: Sensitivity antibiotics

Drug: Esomeprazole

Drug: Colloidal Bismuth Subcitrate