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Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

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ClinicalTrials.gov Identifier: NCT03609892
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yongquan Shi, Xijing Hospital of Digestive Diseases

Brief Summary:
This study aims at evaluating efficacy and safety of berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone quadruple therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Condition or disease Intervention/treatment Phase
Gastric Ulcer Chronic Gastritis Gastric Cancer Helicobacter Pylori Infection Gastritis Drug: Berberine Drug: Amoxicillin Drug: Esomeprazole Drug: Bismuth Drug: Tetracycline Drug: Furazolidone Phase 4

Detailed Description:

Detailed Description:

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test,rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 13 and 17.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test,rapid urease test or helicobacter pylori stool antigen test。


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 658 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: berberine plus amoxicillin quadruple therapy
Berberine 500mg three time daily for 14days, amoxicillin 1000 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.
Drug: Berberine
Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ,esomeprazole 20 mg BID, ,and Bismuth 100 mg 2 capsules BID.

Drug: Amoxicillin
Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Amoxicillin 500 mg 2 capsules BID plus berberine 100 mg 3 tablets TID, esomeprazole 20mg 1tablet BID, and bismuth 100 mg 2 capsules BID
Other Name: Amoxy

Drug: Esomeprazole
Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Esomeprazole 20mg 1 tablet BID plus berberine 100 mg 3 tablets TID,amoxicillin 500 mg 2 capsules BID, and bismuth 100 mg 2 capsules BID
Other Name: Nexium

Drug: Bismuth
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID,esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Active Comparator: tetracycline plus furazolidone quadruple therapy
Tetracycline 500mg three time daily for 14days,furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.
Drug: Tetracycline
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsulesTID plus furazolidone 100mg 1 tablets BID,esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Drug: Furazolidone
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus Tetracycline 250mg 2 capsulesTID,esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Drug: Esomeprazole
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of esomeprazole 20 mg 1 tablets BID plus Tetracycline 250mg 2 capsules TID, furazolidone 100mg 1 tablets BID, and bismuth 100 mg 2 capsules BID
Other Name: Nexium

Drug: Bismuth
Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of bismuth 100 mg 2 capsules BID plus Tetracycline 250mg 2 capsules TID ,furazolidone 100mg 1 tablets BID and esomeprazole 20 mg 1 tablets BID




Primary Outcome Measures :
  1. Helicobacter pylori eradication [ Time Frame: 28 days after treatment ]
    The primary end point of this study is H.pylori eradication,established by negative urea breath test,rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.


Secondary Outcome Measures :
  1. symptoms effective rates [ Time Frame: 14 days of treatment, and 28 days after treatment ]

    Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment.

    Symptom effective rate =(total score before treatment - total score after treatment)/total score before treatment x 100%.

    Total score = frequency + severity.

    Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence.

    Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe


  2. adverse events [ Time Frame: 14 days of treatment, and 28 days after treatment ]
    Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who had failed H.pylori eradication therapies before.
  2. Age between 18~70, both gender.
  3. Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 2 months.
  4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

  1. Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
  2. Contraindications to study drugs.
  3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
  4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
  5. Pregnant or lactating women.
  6. Underwent upper gastrointestinal Surgery.
  7. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
  8. Evidence of bleeding or iron efficiency anemia.
  9. A history of malignancy.
  10. Drug or alcohol abuse history in the past 1 year.
  11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
  12. Enrolled in other clinical trials in the past 3 months.
  13. Patients who has psychological problem or poor compliance.
  14. Refuse to sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609892


Locations
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China, Shaanxi
Xijing Hosipital of Digestive Disease Recruiting
Xi`an, Shaanxi, China, 710032
Contact: Yongquan Shi, professor    86-029-84771515    shiyquan@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases

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Responsible Party: Yongquan Shi, Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT03609892     History of Changes
Other Study ID Numbers: KY20182043-1
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Helicobacter Infections
Gastritis
Stomach Ulcer
Gram-Negative Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Amoxicillin
Tetracycline
Furazolidone
Esomeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
Protein Synthesis Inhibitors
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents