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Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test

Y

Yonsei University Health System (YUHS)

Status

Unknown

Conditions

Helicobacter Pylori Infection

Treatments

Drug: eradication of Helicobacter pylori

Study type

Interventional

Funder types

Other

Identifiers

NCT02759029
3-2015-0193

Details and patient eligibility

About

Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy are declining, and an alternative strategy is needed urgently. The investigators sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a region with high rates of multiple drug resistance.

Enrollment

123 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. positive results of rapid urease test

Exclusion criteria

  1. liver cirrhosis,
  2. chronic kidney disease,
  3. bleeding tendency,
  4. pregnant,
  5. allergy to antibiotics

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

123 participants in 3 patient groups

Susceptibility-guided group
Active Comparator group
Description:
Drugs according to antimicrobial susceptibility-guided treatment
Treatment:
Drug: eradication of Helicobacter pylori
triple therapy group
Sham Comparator group
Description:
Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk
Treatment:
Drug: eradication of Helicobacter pylori
concomitant therapy group
Sham Comparator group
Description:
Drugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk
Treatment:
Drug: eradication of Helicobacter pylori

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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