Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective Randomized Trial

Helicobacter Pylori Eradication Clinical Trial

Official title:

Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective, Single-center, Open-label, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870397
• Other study ID #: 2023-0184
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: August 21, 2024

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuehua Han, MD
• Phone: +86057189713734
• Email: 13858126927[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although Urea breath test has been commonly used to recheck the efficiency of Helicobacter pylori eradication, there has been no randomized trials comparing the accuracy of Urea breath test results at different times after eradication. The investigators aim to assess the accuracy and influence factors of post-therapy test at different times and follow up the cut off samples to optimize the best time to recheck.

Description:

The investigators plan to conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after the treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: August 21, 2024
• Est. primary completion date: April 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• no history of helicobacter pylori treatment
• the diagnosis of H. pylori infection was confirmed by one or more of the following methodologies before treatment: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), and/or the 13C-UBT.

Exclusion Criteria:

• used antibiotics or bismuth within four weeks before inclusion or acid inhibitor use, including H2 receptor antagonist (H2RA), PPI or P-CAB use, within two weeks prior to inclusion.
• had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction.
• had a history of esophagectomy or gastrectomy.
• had an allergy to any study drug.
• had severe comorbidities or physical or mental diseases.
• were pregnant or breastfeeding.
• had a history of alcohol abuse or drug addiction.

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication

Intervention

Diagnostic Test:
• HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times
Carbon 13 breath tests are generally performed 4-6 weeks after eradication therapy. The control group will perform breath urea test at 4-6 weeks after treatment. The experimental groups will perform the same test at different times after the same treatment, 6-8weeks and 8-10 weeks, respectively.

Locations

Country	Name	City	State
China	2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the eradication rate in each group (ITT analysis)	According to the breath urea test, calculation the eradication rate in the three groups. ITT analysis, the number of negative breath test cases after treatment divided by the number of cases enrolled in eradication therapy.	up to 4 months after eradication therapy
Primary	the eradication rate in each group (PP analysis)	According to the breath urea test, calculation the eradication rate in the three groups. PP analysis, the number of negative breath test cases after treatment divided by the number of cases finished the eradication therapy	up to 4 months after eradication therapy
Secondary	follow up of cut off cases	If the result of breath urea test is betwwen 2 to 6, it will be defined as cut off value. These cases will be collected and take further tests to make sure the real situation of helicobacter pylori infection.	up to 4 months after eradication therapy.