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

Helicobacter Infection Clinical Trial

Official title:

A Prospective, Single-center, Open-label, Clinical Trial to Compare the 10-day Sequential Therapy and 7-day Culture Based Tailored Therapy for the Eradication of Helicobacter Pylori

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02373280
• Other study ID #: B-1407/259-005
• Status: Recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Seoul National University Bundang Hospital
• Contact: Nayoung Kim, M.D., Ph. D
• Phone: 82-31-787-7008
• Email: nayoungkim49[@]empas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

As increasing antimicrobial resistance in Korea, the effectiveness of empirical Helicobacter pylori (H. pylori) therapies have been declined. Recently, 10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication.

Thus, in this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days tailored therapy (7 day PPI based triple therapy, bismuth quadruple therapy or moxifloxacin contained triple therapy) for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 day sequential therapy for the first eradication of H. pylori infection, and the investigators analyzed the prevalence of the antibiotic resistance in the tailored therapy group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• The patients who proved H. pylori infection following three methods

1. positive rapid urease test (CLOtest)

2. histologic evidence of H. pylori by modified Giemsa staining

3. positive Urea breath test

• Male and female Korean Adult (Aged = 18 years)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Helicobacter Infection
• Helicobacter Infections
• Infections

Intervention

Drug:
• 10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)
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).
• 7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)
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)]
• 7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]
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)].
• 7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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