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

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Doxycycline; Drug: Furazolidone; Drug: Esomeprazole; Drug: Colloidal Bismuth Subcitrate; Drug: Sensitivity antibiotics

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: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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	Drug: Doxycycline; Doxycycline 100g po bid; Other Names: Vibramycin; Drug: Furazolidone; Furazolidone 100mg po bid; Other Names: Giarlan; Drug: Esomeprazole; Esomeprazole 20mg po bid; Other Names: Nexium; Drug: Colloidal Bismuth Subcitrate; Bismuth 20mg po bid; Other Names: PIDI
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	Drug: Esomeprazole; Esomeprazole 20mg po bid; Other Names: Nexium; Drug: Colloidal Bismuth Subcitrate; Bismuth 20mg po bid; Other Names: PIDI; Drug: Sensitivity antibiotics; 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	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	Number of participants whose symptoms disappear or improve after eradication treatment.	14 days and 42 days after H.pylori eradication
Side effects	Adverse Events That Are Related to Eradication Treatment	14 days after start of therapy
Adherence rate	Number of patients who take at least 80% drugs	14 days after start of therapy

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• 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): February 1, 2016
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: September 3, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

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)?: No