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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Eradication
• Intervention / Treatment: Diagnostic test: HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuehua Han, MD; Phone Number: +86057189713734; Email: 13858126927@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China
      • Contact: Yuehua Han, MD; Phone Number: +8613858126927; Email: 13858126927@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Recheck time is at 4 to 6 weeks after the eradication therapy; All cases are administered 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 4 to 6 weeks( as guildeline suggested) after the treatment.	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.
Active Comparator: Recheck time is at 6 to 8 weeks after eradication therapy; All cases are administered 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 6 to8 weeks after the treatment.	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.
Active Comparator: Recheck time is at 8 to 10 weeks after eradication therapy; All cases are administered 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 8 to 10 weeks after the treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Jianting Cai, MD, 2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Anticipated): April 21, 2024
• Study Completion (Anticipated): August 21, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023-0184

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No