Personalized Treatment for Refractory H Pylori Infection

NCT02547025 | Completed DMC

• 1 other identifier: VGHKS13-CT12-17
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; third-line therapy; antibiotic susceptibility; Eradication

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Which H. Pylori Was Eradicated

  To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

  eight weeks after the end of anti-H pylori therapy

Study Arms (3)

rabeprazole+3 antibiotics

EXPERIMENTAL

patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days

Drug: rabeprazole+3 antibiotics

rabeprazole+bismuth+2 antibiotics

EXPERIMENTAL

patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days

Drug: rabeprazole+bismuth+2 antibiotics

rabeprazole+amox+tetr+levo

ACTIVE COMPARATOR

patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days

Drug: rabeprazole+amox+tetr+levo

Interventions

rabeprazole+3 antibiotics DRUG

(rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.

Also known as: rabeprazole 20 mg, amoxicillin 1g, clarithromycin 500mg, metrondazole 250mg, tetracycline 500mg, levofloxacin 500mg

rabeprazole+3 antibiotics

rabeprazole+bismuth+2 antibiotics DRUG

(rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.

Also known as: rabeprazole 20 mg, bismuth subcitrate 120 mg, amoxicillin 1g, clarithromycin 500mg, metrondazole 250mg, tetracycline 500mg, levofloxacin 500mg

rabeprazole+bismuth+2 antibiotics

rabeprazole+amox+tetr+levo DRUG

(rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Also known as: rabeprazole 20 mg, bismuth subcitrate 120 mg, tetracycline 500mg, levofloxacin 500mg

rabeprazole+amox+tetr+levo

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.
• positive results of both rapid urease test and histology,
• a positive result of Urea breath test,
• or a positive result of culture

You may not qualify if:

• ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks,
• patients with allergic history to the medications used,
• patients with previous gastric surgery,
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
• pregnant women.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (27)

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MeSH Terms

Interventions

Rabeprazole; Amoxicillin; Clarithromycin; Tetracycline; Levofloxacin; bismuth tripotassium dicitrate

Intervention Hierarchy (Ancestors)

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; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Ping-I Hsu, Bachelor

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

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

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 11, 2015
• Study Start: August 1, 2012
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

TW (1)