Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894268
• Other study ID #: 20160513-1
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Sir Run Run Shaw Hospital
• Contact: Ning Dai, Chief
• Phone: +86138-6745-7664
• Email: 2267454962[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Doxycycline
Doxycycline 100g po bid
• Furazolidone
Furazolidone 100mg po bid
• Esomeprazole
Esomeprazole 20mg po bid
• Colloidal Bismuth Subcitrate
Bismuth 20mg po bid
• Sensitivity antibiotics
Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital,Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Epu — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori eradication rate	Repeat 13-Urea breath test 42 days after H.pylori eradication	42 days after start of therapy
Secondary	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
Secondary	Side effects	Adverse Events That Are Related to Eradication Treatment	14 days after start of therapy
Secondary	Adherence rate	Number of patients who take at least 80% drugs	14 days after start of therapy