The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

Helicobacter Pylori Clinical Trial

Official title:

The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810793
• Other study ID #: 2020-SDU-QILU-G101
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Description:

Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment in patients with Hp eradication failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients, aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

• Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

Drug:
• Amoxicillin , Levofloxacin and Esomeprazole
Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens
• Amoxicillin , Furazolidone and Esomeprazole
Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens
• Tetracycline , Furazolidone and Esomeprazole
Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens
• Amoxicillin,Levofloxacin and Vonoprazan fumarate
Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group
• Amoxicillin,Furazolidone and Vonoprazan fumarate
Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group
• Tetracycline,Furazolidone and Vonoprazan fumarate
Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (6)

Lead Sponsor	Collaborator
Shandong University	Dezhou People's Hospital, Shengli Oilfield Hospital, Taian City Central Hospital, The Affiliated Hospital of Qingdao University, Weifang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The most suitable re-eradication time	The most suitable re-eradication time will be assessed by paired comparison method .	1year