- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ning Dai, Chief
- Phone Number: +86138-6745-7664
- Email: 2267454962@qq.com
Study Contact Backup
- Name: Weiling Hu, Attending
- Phone Number: +86153-9705-9751
- Email: ringwh@163.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Sir Run Run Shaw Hospital,Zhejiang University
-
Contact:
- Weiling Hu, Attending
- Phone Number: +86153-9705-9751
- Email: ringwh@163.com
-
Principal Investigator:
- Weiling Hu, Atrending
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A positive 13 C-urea breath test
- Formal H.pylori treatment more than two times
- Age >18 years
Exclusion Criteria:
- Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled
- Allergic to the medications
- Upper gastrointestinal surgery history
- Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems
- Evidence of blood dyscrasia
- Pregnant and lactating women
- Can't express his complain correctly and can't cooperate with the researcher
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Regimen A
esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
|
Doxycycline 100g po bid
Other Names:
Furazolidone 100mg po bid
Other Names:
Esomeprazole 20mg po bid
Other Names:
Bismuth 20mg po bid
Other Names:
|
Active Comparator: Regimen B
two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
|
Esomeprazole 20mg po bid
Other Names:
Bismuth 20mg po bid
Other Names:
Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
H. pylori eradication rate
Time Frame: 42 days after start of therapy
|
Repeat 13-Urea breath test 42 days after H.pylori eradication
|
42 days after start of therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment
Time Frame: 14 days and 42 days after H.pylori eradication
|
Number of participants whose symptoms disappear or improve after eradication treatment.
|
14 days and 42 days after H.pylori eradication
|
Side effects
Time Frame: 14 days after start of therapy
|
Adverse Events That Are Related to Eradication Treatment
|
14 days after start of therapy
|
Adherence rate
Time Frame: 14 days after start of therapy
|
Number of patients who take at least 80% drugs
|
14 days after start of therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Weiling Hu, Attending, Sir Run Run Shaw Hospital
Publications and helpful links
General Publications
- Zhang Y, Gao W, Cheng H, Zhang X, Hu F. Tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for Helicobacter pylori infection: a single center retrospective study. Helicobacter. 2014 Oct;19(5):382-6. doi: 10.1111/hel.12143. Epub 2014 May 21.
- Ciccaglione AF, Cellini L, Grossi L, Manzoli L, Marzio L. A Triple and Quadruple Therapy with Doxycycline and Bismuth for First-Line Treatment of Helicobacter pylori Infection: A Pilot Study. Helicobacter. 2015 Oct;20(5):390-6. doi: 10.1111/hel.12209. Epub 2015 Mar 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Infections
- Helicobacter Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Monoamine Oxidase Inhibitors
- Antimalarials
- Antacids
- Anti-Infective Agents, Urinary
- Renal Agents
- Antitrichomonal Agents
- Anti-Bacterial Agents
- Doxycycline
- Esomeprazole
- Bismuth
- Bismuth tripotassium dicitrate
- Furazolidone
Other Study ID Numbers
- 20160513-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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