The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection

NCT02373280 | Recruiting

• 1 other identifier: B-1407/259-005
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.

Conditions

Helicobacter Infection

Keywords

Helicobacter pylori; tailored therapy; eradication

Outcome Measures

Primary Outcomes (1)

• Compare the percentage of participants with successful H. pylori eradication in each groups

  The efficacy of H. pylori eradication between a 7 days tailored therapy for H. pylori infection based on the results of antimicrobial resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 days therapy as first eradication regimen.

  6 weeks after completion of eradication

Study Arms (4)

10 day sequential group

ACTIVE COMPARATOR

After proving H. pylori infection, the participant will receive the empirical 10 day sequential regimen (Esomeprazole, nexium® 40 mg bid 10 days (D1-D10)+amoxicillin® 1 g bid 5 days (D1-D5)+clarithromycin, klaricid® 500mg bid 5 days (D6-D10)+metronidazole, flasinyl® 500mg tid 5 days (D6-D10) for treatment of H. pylori infection in this group.

Drug: 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)

7 days tailored PPI triple therapy group

EXPERIMENTAL

After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day tailored regimen \[PPI triple therapy (Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+amoxicillin® 1 g bid 7 days (D1-D7)+clarithromycin, klaricid® 500mg bid 7 days (D1-D7)\] in this group.

Drug: 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)

7 days tailored MEA therapy group

EXPERIMENTAL

After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day moxifloxacin triple therapy \[Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+Moxifloxacin, avelox® 400 mg qd 7 days (D1-D7)+Amoxicillin® 1 g bid 7 days (D1-D7)\] in this group.

Drug: 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]

7 or 14 days tailored EBMT therapy group

EXPERIMENTAL

After proving H. pylori infection, the participant received endoscopic guided biopsy for H. pylori culture and MIC. Based on antimicrobial susceptibility testing, the participant will receive 7 day bismuth quadruple therapy \[Esomeprazole, nexium® 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, denol® 300 mg qid 7 days (D1-D7)+Metronidazole, flasinyl® 500 mg tid 7 days (D1-D7)+Tetracycline® 500 mg qid 7 days (D1-D7)\] in this group. If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days.

Drug: 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)

Interventions

10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole) DRUG

In this group, patients will receive the 10 day sequential regimen for eradication of H. pylori. 10 day sequential regimen is like follows; Esomeprazole 40 mg bid 10 days (D1-D10)+amoxicillin 1 g bid 5 days (D1-D5)+clarithromycin 500 mg bid 5 days (D6-D10)+metronidazole 500 mg tid 5 days (D6-D10).

10 day sequential group

7 day tailored PPI triple therapy (clarithromycin-containing triple therapy) DRUG

the participants received PPI based triple therapy\[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\]

Also known as: 7d PPI triple therapy

7 days tailored PPI triple therapy group

7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin] DRUG

moxifloxacin triple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)\].

Also known as: 7d MEA triple therapy

7 days tailored MEA therapy group

7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy) DRUG

bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+amoxicillin 1 g bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)\], bismuth quadruple therapy \[Esomeprazole, 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, 300 mg qid 7 days (D1-D7)+Metronidazole, 500 mg tid 7 days (D1-D7)+Tetracycline 500 mg qid 7 days (D1-D7)\] If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days.

Also known as: 7d or 14d quadruple therapy

7 or 14 days tailored EBMT therapy group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients who proved H. pylori infection following three methods
• positive rapid urease test (CLOtest)
• histologic evidence of H. pylori by modified Giemsa staining
• positive Urea breath test
• Male and female Korean Adult (Aged ≥ 18 years)

You may not qualify if:

• Patients who received eradication therapy for H. pylori infection, previously
• H. pylori eradication failure because of poor compliance
• the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
• Advanced gastric cancer or other malignancy
• Abnormal liver function or liver cirrhosis
• Abnormal renal function or chronic kidney disease
• Other severe concurrent diseases
• Previous allergic reactions to the study drugs
• Pregnant or lactating women

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Esomeprazole; Amoxicillin; Clarithromycin; Metronidazole; Moxifloxacin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Nayoung Kim, M.D., Ph. D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayoung Kim, M.D., Ph. D

CONTACT

82-31-787-7008; nayoungkim49@empas.com

Study Design

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

Model Details: Patients selected study

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 27, 2015
• Study Start: August 1, 2014
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

KR (1)