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Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication

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ClinicalTrials.gov Identifier: NCT03897244
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Up to know, three is few large-scale, randomized study prospectively and simultaneously comparing the efficacy, adverse effects and patient compliance of high-dose dual therapy (HDDT) with or without bismuth versus amoxicillin-metronidazole bismuth quadruple therapy (AM-BQT) as first-line regimens for H. pylori eradication.

The aims of this study are:

  1. to compare the efficacy of HDDT with or without bismuth and AM-BQT as first-line regimens for H. pylori eradication;
  2. to compare the patient adherence and adverse effects of these treatment regimens;
  3. to investigate factors that may influence H. pylori eradication by these treatment regimens;
  4. to identify the effect of H. pylori eradication on the evolution of ecosystem of microbiota, and inflammatory parameters.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: High-dose dual therapy (rabeprazole, amoxicillin) Drug: Bismuth High-dose dual therapy (rabeprazole, amoxicillin, tripotassium dicitrate bismuthate) Drug: Amoxicillin-Metronidazole Bismuth quadruple therapy Phase 4

Detailed Description:

This prospective multicenter randomized comparative study will be conducted at the National Taiwan University Hospital(NTUH), NTUH Bei-Hu Branch, NTUH Hsin-Chu Branch, Buddhist Tzu Chi General Hospital, and Mennonite Christian Hospital in Hua-Lien City. Patients, aged >= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease test, histology, and bacterial culture before treatment. If the patients did not receive anti-H. pylori therapy previously, these patients will be invited to enter this study for evaluating the efficacy of these 1st-line regimens.

A computed generated random numbers sequence will be blocked into three subgroups, say A, B, and C. After giving written informed consent, each patient will be randomly allocated, to one of three treatment groups:

group A - HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);

group B - Bis-HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate bismuthate 300 mg qid, for 14 days);

group C - AM-BQT (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid + amoxicillin 1000 mg bid + metronidazole 500 mg tid , for 14 days);

All patients will be asked to complete a questionnaire and to record symptoms, drug consumption, and diet content daily during the treatment period. Post-treatment, the patients will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effects of treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the C13-urea breath test (UBT). The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method. A part of participants, at least 30 cases in each group, will be invited to join a follow-up program for one year for evaluating the changes or evolution of gut microbiota composition, metabolic product, parameters of inflammation and immune response.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 702 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacies of High-dose Dual Therapy With or Without Bismuth Versus Amoxicillin-metronidazole Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication - A Prospective, Randomized, Comparative Study
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: High-dose dual therapy
group A - HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid, for 14 days)
Drug: High-dose dual therapy (rabeprazole, amoxicillin)
High-dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid, for 14 days)
Other Names:
  • Proton pump inhibitor, Rabeprazole, Pariet®
  • Antibiotics, Amoxicillin ,Amoxicillin®

Experimental: Bismuth High-dose dual therapy
group B - Bis-HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate bismuthate 300 mg qid, for 14 days)
Drug: Bismuth High-dose dual therapy (rabeprazole, amoxicillin, tripotassium dicitrate bismuthate)
Bismuth-High-dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate bismuthate 300 mg qid, for 14 days)
Other Names:
  • Proton pump inhibitor, Rabeprazole, Pariet®
  • Antibiotics, Amoxicillin ,Amoxicillin®
  • Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®

Active Comparator: Amoxicillin-Metronidazole Bismuth quadruple therapy
group C - AM-BQT (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid + amoxicillin 1000 mg bid + metronidazole 500 mg tid, for 14 days)
Drug: Amoxicillin-Metronidazole Bismuth quadruple therapy
Amoxicillin-Metronidazole Bismuth quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid + amoxicillin 1000 mg bid + metronidazole 500 mg tid, for 14 days)
Other Names:
  • Proton pump inhibitor, Rabeprazole, Pariet®
  • Antibiotics, Amoxicillin, Amoxicillin®
  • Antibiotics, Metronidazole, Flagyl®
  • Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®




Primary Outcome Measures :
  1. to compare the eradication rate of HDDT with or without bismuth and AM-BQT as first-line regimens for H. pylori eradication. [ Time Frame: 3.5 years ]
    The eradication rates (efficacy) of these regimens will be evaluated by the results of C13-urea breath test.


Secondary Outcome Measures :
  1. to compare the patient adherence and frequency of adverse effects of these treatment regimens. [ Time Frame: 3.5 years ]
    The frequency of adverse events will be evaluated by the number of participant with adverse events and patient adherence will be evaluated by counting unused medication after the treatment.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

inclusion criteria: participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received first-line eradication therapy.

Exclusion criteria:

  1. pregnant or nursing woman;
  2. serious concomitant illness and malignant tumor of any kind;
  3. history of hypersensitivity to test drugs;
  4. serious bleeding during the course of this ulcer;
  5. previous gastric surgery;
  6. receiving bismuth salts, proton pump inhibitors (PPIs), or antibiotics in the previous month.

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): NCT03897244


Contacts
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Contact: Jyh-Chin Yang, M.D.Ph.D. 02-23123456 ext 65055 jcyang47@ntu.edu.tw
Contact: Chien-Chih Tung, M.D. 02-23123456 ext 66518 cnicemike@yahoo.com.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Jyh-Chin Yang, M.D.Ph.D.    02-23123456 ext 65055    jcyang47@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Jyh-Chin Yang, M.D.Ph.D. National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03897244     History of Changes
Other Study ID Numbers: 201812129MINC
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Helicobacter pylori
high dose dual therapy
bismuth high-dose dual therapy
bismuth quadruple therapy
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Amoxicillin
Metronidazole
Antibiotics, Antitubercular
Rabeprazole
Bismuth
Proton Pump Inhibitors
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids