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Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy

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ClinicalTrials.gov Identifier: NCT02296021
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : September 3, 2015
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-containing quadruple therapy(berberine, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

Condition or disease Intervention/treatment Phase
Gastritis Peptic Ulcer Dyspepsia Drug: Berberine Drug: Bismuth Drug: esomeprazole Drug: amoxicillin Drug: clarithromycin Phase 4

Detailed Description:

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath 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 12 and 14.

Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Eradication With Berberine Hydrochloride,Esomeprazole,Amoxicillin and Clarithromycin Versus Bismuth,Esomeprazole,Amoxicillin,and Clarithromycin: a Randomized,Open-label, Non-inferiority, Phase Ⅳ Trail
Study Start Date : November 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: berberine quadruple therapy
Berberine 500 mg, esomeprazole 20 mg,amoxicillin 1000 mg, and clarithromycin 500 mg by mouth, twice daily for 14 days.
Drug: Berberine
Berberine-containing quadruple therapy group: given for 14 days at a dose of berberine 100 mg 5 tablets BID, esomeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Drug: esomeprazole
Esmeprazole 20mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Other Name: Nexium

Drug: amoxicillin
Amoxicillin 500 mg 2 capsules BID plus esmeprazole 20mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Other Name: Amoxy ( Uni-Amocin )

Drug: clarithromycin
Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 20mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.

Active Comparator: bismuth quadruple therapy
Bismuth 220 mg, esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Drug: Bismuth
Bismuth-containing quadruple therapy group: given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
Other Names:
  • Bitnal
  • colloidal bismuth tartrate capsule

Drug: esomeprazole
Esmeprazole 20mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Other Name: Nexium

Drug: amoxicillin
Amoxicillin 500 mg 2 capsules BID plus esmeprazole 20mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Other Name: Amoxy ( Uni-Amocin )

Drug: clarithromycin
Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 20mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.




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 [13C] urea breath test 28 days after the end of eradication.


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.



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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. Age between 18~70,both gender.
  2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
  3. Patients are willing to receive eradication treatment.
  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 antibiotics to eradicate adequately recorded 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 eficiency 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.

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): NCT02296021


Locations
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China, Shanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Investigators
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Principal Investigator: Yongquan Shi, Ph. D Xijing Hospital

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Responsible Party: Yongquan Shi, Professor/Chief Physician, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT02296021     History of Changes
Other Study ID Numbers: KY20140916-2
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015

Keywords provided by Yongquan Shi, Xijing Hospital of Digestive Diseases:
helicobacter pylori
berberine-containing quadruple therapy
bismuth-containing quadruple therapy

Additional relevant MeSH terms:
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Dyspepsia
Peptic Ulcer
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastroenteritis
Amoxicillin
Clarithromycin
Esomeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids