Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection

NCT03361267 | Unknown DMC

• 1 other identifier: Inha helicobacter study
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

As the antibiotic resistance increases, the eradication rate of triple therapy is decreasing. Recent guideline recommend the use of bismuth-containing quadruple therapy in areas where clarithromycin resistance is greater than 15%. However, the ideal treatment would be the tailored therapy which choose the antibiotics depending on the antibiotic resistance. This study compared the eradication rates, safety and complicance of tailored therapy compared with empirical bismuth quadruple therapy in the naive patients with H. pylori infection.

Conditions

Helicobacter Pylori Infection; Compliance, Patient; Drug Resistance; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test or CLO test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value). or negative from CLO test

  Six weeks after completion of therapy

Secondary Outcomes (3)

• Rate of adverse effects

  within 7 days after completion of therapy

• Compliance rate

  within 7 days after completion of therapy

• Medical cost

  two months after completion of therapy ]

Study Arms (2)

Bismuth containing quadruple therapy

ACTIVE COMPARATOR

If CLO test is positive, Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 5100 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) are prescribed for 7 days If CLO test is negative, no intervention is needed

Diagnostic Test: CLO test

tailored therapy

EXPERIMENTAL

If H. pylori PCR is negative, no intervention is needed If H. pylori PCR is positive and mutation is negative, triple regimen (rabeprazole 20 mg bid, amoxacillin 1000 mg bid, clarithromycin 500mg bid) are prescribed for 7 days is given If H. pylori PCR is positive and mutation is positive, Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 5100 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) are prescribed for 7 days is given

Diagnostic Test: Helicobacter pylori PCR test

Interventions

Helicobacter pylori PCR test DIAGNOSTIC_TEST

Clarithromycin resistance (-) Triple therapy (rabeprazole 20 mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid) for 7 days Clarithromycin resistance (+) Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 500 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) for 7 days

tailored therapy

CLO test DIAGNOSTIC_TEST

CLO test : negative --\> drop out CLO test : postive --\> bismuth containing quadruple therapy

Bismuth containing quadruple therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with peptic ulcer, s/p ESD due to early gastric cancer/gastric adenoma, Maltoma
• Ability and willingness to participate in the study and to sign and give informed consent
• confirmed H. pylori infection

You may not qualify if:

• Previous H. pylori eradication therapy
• Less than 18 years old
• With history of H. pylori infection treatment
• With previous gastric surgery
• Major systemic diseases
• Pregnancy or lactation
• Allergy to any of the study drugs

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Inha University Hospital

Incheon, 22332, South Korea

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Byoung Wook Bang, M.D. phD

CONTACT

+82-32-890-2548; bangbu@inha.ac.kr

Hyung Kil Kim, M.D. phD

CONTACT

+82-32-890-2548; kimhg@inha.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Inha University Hospital

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: December 30, 2017
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)