Clinical trial NCT05614934: Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
Official title: Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori
vonoprazan
standard triple therapy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Open-labeled, prospective, three-arm, parallel-group, non-placebo Randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.

The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

Detailed description: 1. Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics
4. Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented
5. Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device
6. Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)
7. Following up treatment side effects while taking the medications.
8. Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.
9. Assessing patient compliance to different regimens during the final visit.
10. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
11. Results, conclusion, discussion and recommendations will be given.

Eligibility criteria: Inclusion Criteria:

* Patients with positive stool antigen test result for H. pylori
* Patients recently diagnosed with H. pylori infection and did not receive any treatment

Exclusion Criteria:

* Patients sensitive to any of the regimens' components
* Patients who had received a previous eradication therapy and still show positive test results
* Recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month
* Patients with gastric malignancy or who underwent previous gastric surgery
* Pregnancy and lactation
* Patients with major concomitant diseases, including psychic disorders

Primary outcomes:
measure: Determination of the eradication rates for each regimen
timeFrame: 1.5 month
Secondary outcomes:
measure: Determination of number of compliant participants to each regimen
timeFrame: 1.5 month
measure: Determination of number of participants with treatment related adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University outpatient clinics
Study officials:
References: