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Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection

ConditionHELICOBACTER PYLORI INFECTIONS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorTanta University

About this trial

this Study Evaluating Safety and Effectiveness of (Proton Pump Inhibitor versus Vonoprazan) Based Triple Therapy with or without Zinc to Eradicate H. pylori Infection

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18.

Both males and females.

Patients who are positive for H.pylori infection by non-invasive Stool Antigen Test (SAT).

Disqualifiers

Prior H. pylori treatment: Previous treatment for H. pylori infection.

Allergies: Known allergies to study medications or components.

Patients cannot finish treatment course.

Pregnant and Lactating Women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • zinc sulfate

    Drug

    Effect of using Zinc in Helicobacter pylori Treatment

  • Vonoprazan + amoxicillin + clarithromycin

    Drug

    Effect of using Vonoprazan + amoxicillin + clarithromycin in Helicobacter pylori Treatment

  • proton pump inhibitor + amoxicillin

    Drug

    Effect of using proton pump inhibitor + amoxicillin in Helicobacter pylori Treatment

Treatment groups

88 Participants
are divided into 4 treatment groups
Group A: proton pump inhibitor (PPI) with amoxicillin , without addition of zinc sulphateActive comparator 1 intervention
Group B: proton pump inhibitor (PPI) with amoxicillin , with addition of zinc sulphateActive comparator 2 interventions
Group C: vonoprazan with amoxicillin and clarithromycin without using zinc sulphateActive comparator 1 intervention
Group D: vonoprazan with amoxicillin and clarithromycin with addition of zinc sulphateActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Serum interleukin-6 (IL-6) level: will be assessed by ELISA

\- Blood samples: collected from all participants at base line before PPI based triple therapy (Omeprazole /pantoprazole 40mg with amoxicillin 1000mg and clarithromycin 500mg twice daily), 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc and P-CABs based triple therapy (Vonoprazan 20 mg and amoxicillin 1000mg plus clarithromycin 500 mg twice daily) , and then 4 weeks after finishing the treatment from each group for the assessment of the f by Serum interleukin-6 (IL-6) level: will be assessed by ELISA.

Time frame
8 weeks
2

H. pylori stool antigen test (SAT)

\- H. pylori stool antigen test (SAT): test at base line for diagnosis and then 4 weeks after finishing the treatment

Time frame
8 weeks
3

Serum Pepsinogen level: will be assessed by ELISA.

Blood samples: collected from all participants at base line before PPI based triple therapy (Omeprazole /pantoprazole 40mg with amoxicillin 1000mg and clarithromycin 500mg twice daily), 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc and P-CABs based triple therapy (Vonoprazan 20 mg and amoxicillin 1000mg plus clarithromycin 500 mg twice daily) , and then 4 weeks after finishing the treatment from each group for the assessment of the f by Serum Pepsinogen level: will be assessed by ELISA.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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