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

NCT05870397 | Unknown

• 1 other identifier: 2023-0184
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Eradication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• follow up of cut off cases

  up to 4 months after eradication therapy.

Study Arms (3)

Recheck time is at 4 to 6 weeks after the eradication therapy

PLACEBO COMPARATOR

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

Recheck time is at 6 to 8 weeks after eradication therapy

ACTIVE COMPARATOR

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

Recheck time is at 8 to 10 weeks after eradication therapy

ACTIVE COMPARATOR

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

Interventions

HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times DIAGNOSTIC_TEST

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.

Recheck time is at 4 to 6 weeks after the eradication therapy; Recheck time is at 6 to 8 weeks after eradication therapy; Recheck time is at 8 to 10 weeks after eradication therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Jianting Cai, MD

  2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China

  STUDY CHAIR

Central Study Contacts

Yuehua Han, MD

CONTACT

+86057189713734; 13858126927@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will 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 treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 23, 2023
• Study Start: April 21, 2023
• Primary Completion: April 21, 2024
• Study Completion: August 21, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-04

Locations

CN (1)