Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy
Primary Purpose
Helicobacter Pylori Infection
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Doxycycline
Furazolidone
Esomeprazole
Colloidal Bismuth Subcitrate
Sensitivity antibiotics
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection
Eligibility Criteria
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
Sites / Locations
- Sir Run Run Shaw Hospital,Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Regimen A
Regimen B
Arm Description
esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
Outcomes
Primary Outcome Measures
H. pylori eradication rate
Repeat 13-Urea breath test 42 days after H.pylori eradication
Secondary Outcome Measures
Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment
Number of participants whose symptoms disappear or improve after eradication treatment.
Side effects
Adverse Events That Are Related to Eradication Treatment
Adherence rate
Number of patients who take at least 80% drugs
Full Information
NCT ID
NCT02894268
First Posted
August 25, 2016
Last Updated
September 4, 2018
Sponsor
Sir Run Run Shaw Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02894268
Brief Title
Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy
Official Title
Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regimen A
Arm Type
Experimental
Arm Description
esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
Arm Title
Regimen B
Arm Type
Active Comparator
Arm Description
two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Vibramycin
Intervention Description
Doxycycline 100g po bid
Intervention Type
Drug
Intervention Name(s)
Furazolidone
Other Intervention Name(s)
Giarlan
Intervention Description
Furazolidone 100mg po bid
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
Esomeprazole 20mg po bid
Intervention Type
Drug
Intervention Name(s)
Colloidal Bismuth Subcitrate
Other Intervention Name(s)
PIDI
Intervention Description
Bismuth 20mg po bid
Intervention Type
Drug
Intervention Name(s)
Sensitivity antibiotics
Intervention Description
Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.
Primary Outcome Measure Information:
Title
H. pylori eradication rate
Description
Repeat 13-Urea breath test 42 days after H.pylori eradication
Time Frame
42 days after start of therapy
Secondary Outcome Measure Information:
Title
Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment
Description
Number of participants whose symptoms disappear or improve after eradication treatment.
Time Frame
14 days and 42 days after H.pylori eradication
Title
Side effects
Description
Adverse Events That Are Related to Eradication Treatment
Time Frame
14 days after start of therapy
Title
Adherence rate
Description
Number of patients who take at least 80% drugs
Time Frame
14 days after start of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Dai, Chief
Phone
+86138-6745-7664
Email
2267454962@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weiling Hu, Attending
Phone
+86153-9705-9751
Email
ringwh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiling Hu, Attending
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Run Run Shaw Hospital,Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiling Hu, Attending
Phone
+86153-9705-9751
Email
ringwh@163.com
First Name & Middle Initial & Last Name & Degree
Weiling Hu, Atrending
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24849129
Citation
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.
Results Reference
background
PubMed Identifier
25801708
Citation
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.
Results Reference
result
Learn more about this trial
Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy
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