Helicobacter Pylori Infection
Conditions
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.
Interventions
DRUGDoxycycline
Doxycycline 100g po bid
DRUGFurazolidone
Furazolidone 100mg po bid
DRUGEsomeprazole
Esomeprazole 20mg po bid
DRUGColloidal Bismuth Subcitrate
Bismuth 20mg po bid
DRUGSensitivity antibiotics
Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H. pylori eradication rate | 42 days after start of therapy | Repeat 13-Urea breath test 42 days after H.pylori eradication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactNing Dai, Chief
Backup ContactWeiling Hu, Attending
Outcome results
None listed