Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID07293910

Safety and Efficacy of Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection

Led by Tanta University · Updated on 2026-02-13

66

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Helicobacter pylori is a spiral-shaped bacterium that infects up to half of the world's population and is linked to serious stomach problems, including chronic gastritis, ulcers, and stomach cancer. This research compares the safety and effectiveness of Vonoprazan, a new acid-blocking drug, against the standard proton pump inhibitor (PPI) therapy combined with either Vitamin D or probiotics. The study aims to find better treatments due to declining success rates of current therapies caused by antibiotic resistance and side effects. Participants are divided into three groups: one receives Vonoprazan with antibiotics amoxicillin and clarithromycin twice daily for two weeks; the second gets a PPI with the same antibiotics plus probiotics three times daily for two weeks; and the third group receives a PPI with antibiotics plus Vitamin D once daily for two weeks. The study evaluates these therapies to see which better eradicates the infection. During the trial, researchers monitor patients for infection clearance using stool antigen tests four weeks after treatment. They also measure changes in blood markers related to inflammation and oxidative stress, and track gastrointestinal symptoms using questionnaires from the start of therapy until four weeks after completion. The total participation period includes treatment and follow-up assessments to evaluate safety and effectiveness.

CONDITIONS

Brief Title

Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Both male and female patients.
  • Patients aged 18 to less than 80 years.
  • Confirmed diagnosis of Helicobacter pylori infection by stool antigen test, urea breath test, or endoscopy.
Not Eligible

You will not qualify if you...

  • Pregnant or lactating patients.
  • Patients with inflammatory diseases.
  • Patients sensitive to any components of the treatment regimens.
  • Patients who received previous eradication therapy or used antimicrobial agents, proton pump inhibitors, or H2 receptor blockers within the past month.
  • Patients with previous gastric or duodenal bleeding, gastric surgery, or gastric cancer.
  • Patients with active liver disease or renal impairment.
  • Concurrent use of liver enzyme inducers, inhibitors, or drugs with high plasma protein binding.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive triple therapy with either vonoprazan or proton pump inhibitor combined with amoxicillin and clarithromycin, along with either vitamin D or probiotics, to eradicate Helicobacter pylori infection.

Twice daily medication intake for 2 weeks; probiotic or vitamin D dosing as applicable

Follow-up

Duration - 4 weeks after completion of therapy

Participants are monitored to assess Helicobacter pylori eradication and changes in biological markers and gastrointestinal symptoms after completing therapy.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Tanta university hospital

Tanta, Egypt

Actively Recruiting

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Research Team

H

Hagar Khaled Dewidar, Msc in Clinical Pharmacy

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

Human cathelicidin antimicrobial peptide (CAMP) gene is a direct target of the vitamin D receptor and is strongly up-regulated in myeloid cells by 1,25-dihydroxyvitamin D3.

Adrian F Gombart, Niels Borregaard, H Phillip Koeffler

https://pubmed.ncbi.nlm.nih.gov/15985530

Indene Compounds Synthetically Derived from Vitamin D Have Selective Antibacterial Action on Helicobacter pylori.

Kiyofumi Wanibuchi, Kouichi Hosoda, Masato Ihara...

https://pubmed.ncbi.nlm.nih.gov/29766504

Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study.

Kazunari Murakami, Yuuichi Sakurai, Madoka Shiino...

https://pubmed.ncbi.nlm.nih.gov/26935876

1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438), a novel and potent potassium-competitive acid blocker for the treatment of acid-related diseases.

Yasunobu Hori, Akio Imanishi, Jun Matsukawa...

https://pubmed.ncbi.nlm.nih.gov/20624992