Clinical trial NCT02894268: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: 42 days after start of therapy
Secondary outcomes:
measure: Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment
timeFrame: 14 days and 42 days after H.pylori eradication
measure: Side effects
timeFrame: 14 days after start of therapy
measure: Adherence rate
timeFrame: 14 days after start of therapy
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital,Zhejiang University
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Weiling Hu, Attending
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.