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

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Doxycycline; Drug: Esomeprazole; Drug: Furazolidone; Drug: Sensitivity antibiotics; Drug: Colloidal Bismuth Subcitrate

• Registration Number: NCT02894268
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief 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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-09-03
• Study First Posted: 2016-09-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05
• Primary Completion: 2018-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen B	Sensitivity antibiotics	two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
Regimen A	Colloidal Bismuth Subcitrate	esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
Regimen B	Colloidal Bismuth Subcitrate	two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
Regimen A	Doxycycline	esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
Regimen A	Furazolidone	esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
Regimen B	Esomeprazole	two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
Regimen A	Esomeprazole	esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	42 days after start of therapy	Repeat 13-Urea breath test 42 days after H.pylori eradication

Secondary Outcome Measures

Name	Time	Method
Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment	14 days and 42 days after H.pylori eradication	Number of participants whose symptoms disappear or improve after eradication treatment.
Side effects	14 days after start of therapy	Adverse Events That Are Related to Eradication Treatment
Adherence rate	14 days after start of therapy	Number of patients who take at least 80% drugs

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital,Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China