Comparing the Efficacy of 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth Therapy

Helicobacter Pylori Infection Clinical Trial

Official title:

Compare 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth on Helicobacter Pylori Eradication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321773
• Other study ID #: VGHKS16-CT10-17
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: Kaohsiung Veterans General Hospital.
• Contact: Feng-Woei Tsay, Bachelor
• Phone: +886-7-342-2121
• Email: fwchaie[@]vghks.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus bismuth) remains unanswered

Description:

With the rising prevalence of antimicrobial resistance, the failure rate of the 7-day standard triple therapy has declined to unacceptable level (<80%) worldwide. Several regimens were suggested to replace standard triple therapy in the area with high clarithromycin resistance, including sequential therapy, concomitant therapy, hybrid therapy and bismuth containing quadruple therapy. A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving eradication rates of 95%. A clinical trial by Hsu et al from our hospital showed 12-day reverse hybrid therapy also achieved high eradication rate, and improved the compliance of patients. Even prolong the treatment duration of standard triple therapy from 7 days to 12 days, the efficacy of eradication was still < 90% (85-88%). The limitation of triple therapy in against resistant-stains was still existed. The addition of bismuth (triple therapy plus bismuth) can improve cure rates despite a high prevalence of antimicrobial resistance. The major bismuth effect is to add an additional 30%-40% to the success with resistant infections. However the direct compare the efficacy between 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is still insufficiency in Taiwan and worldwide. Choosing a navel therapy or a modifying triple therapy can get better efficacy, it is remained to be determined. Besides genotyping polymorphism of CYP2C19 influenced the metabolism of proton pump inhibit, and could cause decreasing of eradication rate of standard triple therapy. But the influence in 14-day reverse hybrid therapy and 14-day triple therapy plus bismuth is unclear.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

• previous H pylori-eradication therapy

• ingestion of antibiotics or bismuth 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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• triple therapy plus bismuth therapy
pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.
• reverse hybrid therapy
(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	sixth week after the end of anti- H. pylori therapy