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Trial record 14 of 39 for:    "Bacterial Infectious Disease" | "Rabeprazole"

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

Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE May 30, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03897244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • 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®
  • 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®
  • 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®
Study Arms  ICMJE
  • Experimental: High-dose dual therapy
    group A - HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid, for 14 days)
    Intervention: Drug: High-dose dual therapy (rabeprazole, 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)
    Intervention: Drug: Bismuth High-dose dual therapy (rabeprazole, amoxicillin, tripotassium dicitrate bismuthate)
  • 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)
    Intervention: Drug: Amoxicillin-Metronidazole Bismuth quadruple therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2019)
702
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897244
Other Study ID Numbers  ICMJE 201812129MINC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Ministry of Science and Technology, Taiwan
Investigators  ICMJE
Principal Investigator: Jyh-Chin Yang, M.D.Ph.D. National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP