HELICOBACTER PYLORI INFECTIONSPhase 2NCT07293910
Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection
A Phase 2 study testing Vonoparazan, Vitamin D and Probiotic in people with HELICOBACTER PYLORI INFECTIONS and Helicobacter Infection, run by Tanta University at 1 site in Egypt.
Trial summary
Helicobacter pylori is a Gram-negative, spiral-shaped bacterium that infects up to 50% of the world's population, residing in the gastric mucosa and using the mucus layer for protection from the stomach's high acidity. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS, Helicobacter Infection, Helicobacter Pylori Gastrointestinal Tract Infection
- What is being tested?
- Vonoparazan, Vitamin D and Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2026to 20 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both male and female patients. • Patients ≥ 18 and <80 years old.
- Patients with confirmed diagnosis of H. pylori infection using either stool antigen test, urea breath test or endoscopy (n=66) Patient whom are confirmed to be H-pylori negative using either stool antigen test, urea breath test or endoscopy (n=66)
Who cannot join
- Pregnant or lactating patients. • Patients with inflammatory diseases. • Patients sensitive to any of the regimens' components. • Patients who had received a previous eradication therapy, recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month.
- Patients with previous incidents of gastric or duodenal bleeding, gastric surgery or gastric malignancy.
- Patients with active liver disease.
- Patients with renal impairment.
- Concurrent use of liver enzyme inducers, inhibitors or drugs with high plasma protein binding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National liver institute - Menoufia university - egypt
Shibīn al Kawm
About this study
Official title: Safety and Efficacy of Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection
Helicobacter pylori is a Gram-negative, spiral-shaped bacterium that infects up to 50% of the world's population, residing in the gastric mucosa and using the mucus layer for protection from the stomach's high acidity. Its clinical significance is profound: it is classified as a Group 1 carcinogen by the World Health Organization and is a primary cause of chronic gastritis, peptic ulcers, gastric lymphoma, and gastric carcinoma. The current first-line treatment, a PPI-based triple therapy (PPI + clarithromycin + amoxicillin), is experiencing a decline in efficacy (cure rates of 50-70%) due to widespread antibiotic resistance and compliance issues. To overcome this, newer agents like Vonoprazan Fumarate, a Potassium-Competitive Acid Blocker (P-CAB), are being adopted. Vonoprazan works by reversibly inhibiting the H+, K+ ATPase pump achieving stronger and longer-lasting acid suppression than PPIs because it does not require acid activation and is more stable in an acidic environment. In addition to pharmacological treatment, adjunctive therapies show promise. Vitamin D, acting through Vitamin D Receptor (VDR), assists in eradication by upregulating antimicrobial proteins like beta-defensin and cathelicidin, and its metabolite can cause bacterial cell lysis. Probiotics (primarily Lactobacillus and Bifidobacterium strains) enhance eradication rates by restricting bacterial growth, inhibiting adhesion, and exerting an anti-inflammatory effect through decreased interleukin-8 production. Finally, helicobacter pylori infection is marked by significant inflammation and oxidative stress. The bacterial protein TIP alpha induces high levels of the pro-inflammatory cytokine TNF alpha. Furthermore, the infection increases free radical production, leading to oxidative stress reflected by high levels of malondialdehyde. Systemic inflammation is also evident as helicobacter pylori infection is associated with significantly elevated serum C-reactive protein levels, which decrease upon successful eradication.
Aim of the work:
This study aims at evaluating the safety and efficacy of Vonoprazan vs Proton Pump Inhibitor with Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection.
Read the detailed description
Helicobacter pylori (H. pylori) is a gram-negative spiral-shaped bacterium that affects up to 50% of the population worldwide, with a higher prevalence in developing countries. H. pylori is found primarily in the human gastric mucosa, its natural habitat, where it remains close to epithelial cells. H. pylori is attracted to the gastric mucus layer, which offers cover and protection from the high acidity in the stomach and promotes better cell motility.
It has been identified as a group 1 carcinogen by the world health organization (WHO) and is associated with the development of gastric cancer. It is also the most important cause for chronic or atrophic gastritis, peptic ulcer, gastric lymphoma, and gastric carcinoma.
First-line therapy for the treatment of H. pylori infection is a triple therapy consisting of a clarithromycin antibiotic, amoxicillin and proton pump inhibitor (PPI). PPI-based triple therapy has been described to be losing its efficacy against H. pylori, with eradication cure rates ranging as low as 50 to 70%, due to high rates of antibiotic resistance, high rates of antibiotic-associated side effects, and weak compliance. Vonoprazan fumarate is a potassium-competitive acid blocker (P-CAB), which is agent that inhibits H+ ,K+ adenosine triphosphatase (ATPase) through reversible K+ competitive ionic binding that results in the inhibition of gastric acid secretion. Because vonoprazan has a relatively high pKa value and is stable in an acidic environment, it can accumulate in the acidic compartment of gastric parietal cells, unlike PPIs. In addition, vonoprazan does not require acid activation, in contrast to PPIs. Thus, vonoprazan can achieve stronger, longer-lasting suppression of gastric acid secretion than PPIs can. Murakami et al. compared the H. pylori eradication rate of vonoprazan with that of PPIs for patients with gastroduodenal ulcers in a randomized, double-blind,multicenter, parallel-group comparative study. The results demonstrated superiority of vonoprazan to lansoprazole regarding the therapeutic effect on H. pylori eradication.
Vitamin D is a micronutrient that regulates bone metabolism. Through vitamin D receptor (VDR), vitamin D plays biological activities. Several studies have uncovered the relationship between vitamin D and H pylori infection, and vitamin D and H pylori eradication. A previous study reported that infected macrophages upregulate the production of β-defensin to kill H pylori strains by VDR. Vitamin D3 can also induce the VDR- cathelicidin antimicrobial protein (CAMP) signaling pathway to eradicate H. pylori in the stomach. Several studies have found that vitamin D3 decomposition product 1 (VDP1) can induce cell membrane collapse, leading to the lysis of H. pylori cells.
Probiotics refer to a group of beneficial bacteria which are gaining acceptance in improving the eradication rate of H. pylori by restricting its growth (anti-microbial activity) and inhibiting subsequent inflammatory processes related to H. pylori infection. Antimicrobial activity is mainly through inhibition of H. pylori adhesion and invasion of gastric epithelial cells and anti-inflammatory role through decreasing interleukin-8 production. The majority of probiotics are of the genera, Lactobacillus and Bifidobacterium. Both strains mostly possess properties of acid tolerance and antimicrobial activity. It was reported that the eradication rate was higher in patients who received probiotics with standard therapy compared to those patients treated with standard therapy alone. A specific H. pylori protein, tumor necrosis factor alpha (TNF-α)-inducing protein (Tipα), plays a significant role by directly inducing TNF-α and other pro-inflammatory cytokines which contributes to gastritis, peptic ulcers, and gastric cancer. TNF-α level is reported to be higher in individuals infected with H. pylori in comparison to uninfected individuals.
- pylori increases free radicals production which leads to oxidative stress and can involve DNA and gastric tissue damage. It was reported that malondialdehyde (MDA) levels are significantly higher in H. pylori-infected gastric mucosa, compared to normal tissue, and the levels of MDA are significantly decreased after H. pylori eradication. C-reactive protein (CRP) is an acute-phase inflammatory liver protein, it facilitates the recognition of foreign pathogens and the phospholipid constituents of damaged cells. It was reported that CRP serum levels were significantly elevated in H. pylori-infected patients and significantly decreased after H. pylori eradication.
- Conditions
- HELICOBACTER PYLORI INFECTIONS, Helicobacter Infection, Helicobacter Pylori Gastrointestinal Tract Infection, Helicobacter Pylori Infected Patients
- Being tested
- Vonoparazan, Vitamin D, Probiotic, Amoxicillin, Clarithromycin 500 mg
- Keywords
- Helicobacter Pylori, Vonoprazan, Vitamin D, Probiotics, Lactobacillus, C-reactive protein, Tumor necrosis factor alpha, Malondialdehyde
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoparazanDrug
Vonoprazan: Potassium competitive acid blocker
Vitamin DDrug
MIcronutrient
ProbioticDrug
Lactobacillus acidophilus
AmoxicillinDrug
Amoxicillin is penicillin-type antibiotic used to treat a wide range of bacterial infections.
Clarithromycin 500 mgDrug
Clarithromycin is a prescription macrolide antibiotic used to treat a variety of bacterial infections
Proton Pump Inhibitor (PPI) TherapyDrug
Proton Pump Inhibitors (PPIs) are powerful medications that significantly reduce stomach acid production by blocking the H+/K+ ATPase enzymes (proton pumps) in the stomach lining,
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan group | Active comparator | 22 patients will receive vonoprazan (20 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 2 weeks Receives: Drug: Vonoparazan; Drug: Amoxicillin; Drug: Clarithromycin 500 mg |
| Probiotic group | Active comparator | 22 patients will receive proton pump inhibitor-based triple therapy omeprazole /pantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily with lactobacillus acidophilus (5 billion CFU) three times daily for 2 weeks. Receives: Drug: Probiotic; Drug: Amoxicillin; Drug: Clarithromycin 500 mg; Drug: Proton Pump Inhibitor (PPI) Therapy |
| Vitamin D group | Active comparator | 22 patients will receive proton pump inhibitor-based triple therapy omeprazole /pantoprazole (40mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily with vitamin D (2000 I.U.) once daily for 2 weeks. Receives: Drug: Vitamin D; Drug: Amoxicillin; Drug: Clarithromycin 500 mg; Drug: Proton Pump Inhibitor (PPI) Therapy |
| H-pylori negative group | No intervention | 66 patients whom are H-pylori negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of H pylori eradication difference among the three intervention groups through stool antigen test 4 weeks after completion of therapy.
We will asses the presence or absence of H pylori through fecal antigen test four weeks after completion of therapy among the three intervention groups It will be assessed as either positive or negative
Measured: 4 weeks after completion of therapy
Secondary outcomes (3)
Changes in serum levels of the measured biological markers
The secondary outcome is the changes in serum levels of TNF-alpha, C-reactive protein and Malondialdehyde 4 weeks after completion of therapy
Measured: 4 weeks after completion of therapy
Change in Gastrointestinal Symptom Rating Scale Questionnaire total score from baseline to completion of therapy and 4 weeks after completion of therapy
change in Gastrointestinal Symptom Rating Scale Questionnaire total score from baseline to completion of therapy and 4 weeks after completion of therapy as it is a validated, 15-item questionnaire used to assess GI symptom severity, grouping symptoms into five clusters: Reflux, Abdominal Pain, Indigestion, Diarrhea, and Constipation, scored on a 1-7 Likert scale (1=no discomfort, 7=very severe).
Measured: From baseline to completion of therapy and 4 weeks after completion of therapy
Assessment CRP levels in both H-pylori positive and negative patients
Comparing the difference in CRP level in H-pylori positive and negative patients
Measured: CRP will be measured at the baseline of the study in both H-pylori positive (n=66) and negative patients (n=66)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Feb 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Khaled Bassuony Dewidar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293910
- Sponsor's protocol ID
- Helicobacter Pylori
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gombart AF, Borregaard N, Koeffler HP. 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. FASEB J. 2005 Jul;19(9):1067-77. doi: 10.1096/fj.04-3284com.
PubMed 15985530Wanibuchi K, Hosoda K, Ihara M, Tajiri K, Sakai Y, Masui H, Takahashi T, Hirai Y, Shimomura H. Indene Compounds Synthetically Derived from Vitamin D Have Selective Antibacterial Action on Helicobacter pylori. Lipids. 2018 Apr;53(4):393-401. doi: 10.1002/lipd.12043. Epub 2018 May 16.
PubMed 29766504Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. 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. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.
PubMed 26935876Hori Y, Imanishi A, Matsukawa J, Tsukimi Y, Nishida H, Arikawa Y, Hirase K, Kajino M, Inatomi N. 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. J Pharmacol Exp Ther. 2010 Oct;335(1):231-8. doi: 10.1124/jpet.110.170274. Epub 2010 Jul 12.
PubMed 20624992Iannone A, Giorgio F, Russo F, Riezzo G, Girardi B, Pricci M, Palmer SC, Barone M, Principi M, Strippoli GF, Di Leo A, Ierardi E. New fecal test for non-invasive Helicobacter pylori detection: A diagnostic accuracy study. World J Gastroenterol. 2018 Jul 21;24(27):3021-3029. doi: 10.3748/wjg.v24.i27.3021.
PubMed 30038469Schreiber S, Konradt M, Groll C, Scheid P, Hanauer G, Werling HO, Josenhans C, Suerbaum S. The spatial orientation of Helicobacter pylori in the gastric mucus. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):5024-9. doi: 10.1073/pnas.0308386101. Epub 2004 Mar 25.
PubMed 15044704Ceylan A, Kirimi E, Tuncer O, Turkdogan K, Ariyuca S, Ceylan N. Prevalence of Helicobacter pylori in children and their family members in a district in Turkey. J Health Popul Nutr. 2007 Dec;25(4):422-7.
PubMed 18402185
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT07293910
- Acronym / sponsor ID
- Helicobacter Pylori
- Conditions
- HELICOBACTER PYLORI INFECTIONS, Helicobacter Infection, Helicobacter Pylori Gastrointestinal Tract Infection, Helicobacter Pylori Infected Patients
- Keywords
- Helicobacter Pylori, Vonoprazan, Vitamin D, Probiotics, Lactobacillus, C-reactive protein, Tumor necrosis factor alpha, Malondialdehyde
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Helicobacter pylori is a Gram-negative, spiral-shaped bacterium that infects up to 50% of the world's population, residing in the gastric mucosa and using the mucus layer for protection from the stomach's high acidity. Its clinical significance is profound: it is classified as a Group 1 carcinogen by the World Health Organization and is a primary cause of chronic gastritis, peptic ulcers, gastric lymphoma, and gastric carcinoma. The current first-line treatment, a PPI-based triple therapy (PPI + clarithromycin + amoxicillin), is experiencing a decline in efficacy (cure rates of 50-70%) due to widespread antibiotic resistance and compliance issues. To overcome this, newer agents like Vonoprazan Fumarate, a Potassium-Competitive Acid Blocker (P-CAB), are being adopted. Vonoprazan works by reversibly inhibiting the H+, K+ ATPase pump achieving stronger and longer-lasting acid suppression than PPIs because it does not require acid activation and is more stable in an acidic environment. In addition to pharmacological treatment, adjunctive therapies show promise. Vitamin D, acting through Vitamin D Receptor (VDR), assists in eradication by upregulating antimicrobial proteins like beta-defensin and cathelicidin, and its metabolite can cause bacterial cell lysis. Probiotics (primarily Lactobacillus and Bifidobacterium strains) enhance eradication rates by restricting bacterial growth, inhibiting adhesion, and exerting an anti-inflammatory effect through decreased interleukin-8 production. Finally, helicobacter pylori infection is marked by significant inflammation and oxidative stress. The bacterial protein TIP alpha induces high levels of the pro-inflammatory cytokine TNF alpha. Furthermore, the infection increases free radical production, leading to oxidative stress reflected by high levels of malondialdehyde. Systemic inflammation is also evident as helicobacter pylori infection is associated with significantly elevated serum C-reactive protein levels, which decrease upon successful eradication.
Aim of the work:
This study aims at evaluating the safety and efficacy of Vonoprazan vs Proton Pump Inhibitor with Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection.
Detailed description
Helicobacter pylori (H. pylori) is a gram-negative spiral-shaped bacterium that affects up to 50% of the population worldwide, with a higher prevalence in developing countries. H. pylori is found primarily in the human gastric mucosa, its natural habitat, where it remains close to epithelial cells. H. pylori is attracted to the gastric mucus layer, which offers cover and protection from the high acidity in the stomach and promotes better cell motility.
It has been identified as a group 1 carcinogen by the world health organization (WHO) and is associated with the development of gastric cancer. It is also the most important cause for chronic or atrophic gastritis, peptic ulcer, gastric lymphoma, and gastric carcinoma.
First-line therapy for the treatment of H. pylori infection is a triple therapy consisting of a clarithromycin antibiotic, amoxicillin and proton pump inhibitor (PPI). PPI-based triple therapy has been described to be losing its efficacy against H. pylori, with eradication cure rates ranging as low as 50 to 70%, due to high rates of antibiotic resistance, high rates of antibiotic-associated side effects, and weak compliance. Vonoprazan fumarate is a potassium-competitive acid blocker (P-CAB), which is agent that inhibits H+ ,K+ adenosine triphosphatase (ATPase) through reversible K+ competitive ionic binding that results in the inhibition of gastric acid secretion. Because vonoprazan has a relatively high pKa value and is stable in an acidic environment, it can accumulate in the acidic compartment of gastric parietal cells, unlike PPIs. In addition, vonoprazan does not require acid activation, in contrast to PPIs. Thus, vonoprazan can achieve stronger, longer-lasting suppression of gastric acid secretion than PPIs can. Murakami et al. compared the H. pylori eradication rate of vonoprazan with that of PPIs for patients with gastroduodenal ulcers in a randomized, double-blind,multicenter, parallel-group comparative study. The results demonstrated superiority of vonoprazan to lansoprazole regarding the therapeutic effect on H. pylori eradication.
Vitamin D is a micronutrient that regulates bone metabolism. Through vitamin D receptor (VDR), vitamin D plays biological activities. Several studies have uncovered the relationship between vitamin D and H pylori infection, and vitamin D and H pylori eradication. A previous study reported that infected macrophages upregulate the production of β-defensin to kill H pylori strains by VDR. Vitamin D3 can also induce the VDR- cathelicidin antimicrobial protein (CAMP) signaling pathway to eradicate H. pylori in the stomach. Several studies have found that vitamin D3 decomposition product 1 (VDP1) can induce cell membrane collapse, leading to the lysis of H. pylori cells.
Probiotics refer to a group of beneficial bacteria which are gaining acceptance in improving the eradication rate of H. pylori by restricting its growth (anti-microbial activity) and inhibiting subsequent inflammatory processes related to H. pylori infection. Antimicrobial activity is mainly through inhibition of H. pylori adhesion and invasion of gastric epithelial cells and anti-inflammatory role through decreasing interleukin-8 production. The majority of probiotics are of the genera, Lactobacillus and Bifidobacterium. Both strains mostly possess properties of acid tolerance and antimicrobial activity. It was reported that the eradication rate was higher in patients who received probiotics with standard therapy compared to those patients treated with standard therapy alone. A specific H. pylori protein, tumor necrosis factor alpha (TNF-α)-inducing protein (Tipα), plays a significant role by directly inducing TNF-α and other pro-inflammatory cytokines which contributes to gastritis, peptic ulcers, and gastric cancer. TNF-α level is reported to be higher in individuals infected with H. pylori in comparison to uninfected individuals.
- pylori increases free radicals production which leads to oxidative stress and can involve DNA and gastric tissue damage. It was reported that malondialdehyde (MDA) levels are significantly higher in H. pylori-infected gastric mucosa, compared to normal tissue, and the levels of MDA are significantly decreased after H. pylori eradication. C-reactive protein (CRP) is an acute-phase inflammatory liver protein, it facilitates the recognition of foreign pathogens and the phospholipid constituents of damaged cells. It was reported that CRP serum levels were significantly elevated in H. pylori-infected patients and significantly decreased after H. pylori eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan group | Active comparator | Drug: Vonoparazan, Drug: Amoxicillin, Drug: Clarithromycin 500 mg22 patients will receive vonoprazan (20 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 2 weeks |
| Probiotic group | Active comparator | Drug: Probiotic, Drug: Amoxicillin, Drug: Clarithromycin 500 mg, Drug: Proton Pump Inhibitor (PPI) Therapy22 patients will receive proton pump inhibitor-based triple therapy omeprazole /pantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily with lactobacillus acidophilus (5 billion CFU) three times daily for 2 weeks. |
| Vitamin D group | Active comparator | Drug: Vitamin D, Drug: Amoxicillin, Drug: Clarithromycin 500 mg, Drug: Proton Pump Inhibitor (PPI) Therapy22 patients will receive proton pump inhibitor-based triple therapy omeprazole /pantoprazole (40mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily with vitamin D (2000 I.U.) once daily for 2 weeks. |
| H-pylori negative group | No intervention | –66 patients whom are H-pylori negative |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both male and female patients. • Patients ≥ 18 and <80 years old.
- Patients with confirmed diagnosis of H. pylori infection using either stool antigen test, urea breath test or endoscopy (n=66) Patient whom are confirmed to be H-pylori negative using either stool antigen test, urea breath test or endoscopy (n=66)
Key exclusion criteria (5 listed)
- Pregnant or lactating patients. • Patients with inflammatory diseases. • Patients sensitive to any of the regimens' components. • Patients who had received a previous eradication therapy, recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month.
- Patients with previous incidents of gastric or duodenal bleeding, gastric surgery or gastric malignancy.
- Patients with active liver disease.
- Patients with renal impairment.
- Concurrent use of liver enzyme inducers, inhibitors or drugs with high plasma protein binding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoparazanVonoprazan: Potassium competitive acid blocker | Drug | Vonoprazan group |
| Vitamin DMIcronutrient | Drug | Vitamin D group |
| ProbioticLactobacillus acidophilus | Drug | Probiotic group |
| AmoxicillinAmoxicillin is penicillin-type antibiotic used to treat a wide range of bacterial infections. | Drug | Probiotic group, Vitamin D group, Vonoprazan group |
| Clarithromycin 500 mgClarithromycin is a prescription macrolide antibiotic used to treat a variety of bacterial infections | Drug | Probiotic group, Vitamin D group, Vonoprazan group |
| Proton Pump Inhibitor (PPI) TherapyProton Pump Inhibitors (PPIs) are powerful medications that significantly reduce stomach acid production by blocking the H+/K+ ATPase enzymes (proton pumps) in the stomach lining, | Drug | Probiotic group, Vitamin D group |
Primary outcome
Detection of H pylori eradication difference among the three intervention groups through stool antigen test 4 weeks after completion of therapy.
Time frame: 4 weeks after completion of therapy
We will asses the presence or absence of H pylori through fecal antigen test four weeks after completion of therapy among the three intervention groups It will be assessed as either positive or negative
3 secondary outcomes
Changes in serum levels of the measured biological markers
Time frame: 4 weeks after completion of therapy
Change in Gastrointestinal Symptom Rating Scale Questionnaire total score from baseline to completion of therapy and 4 weeks after completion of therapy
Time frame: From baseline to completion of therapy and 4 weeks after completion of therapy
Assessment CRP levels in both H-pylori positive and negative patients
Time frame: CRP will be measured at the baseline of the study in both H-pylori positive (n=66) and negative patients (n=66)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 15985530Gombart AF, Borregaard N, Koeffler HP. 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. FASEB J. 2005 Jul;19(9):1067-77. doi: 10.1096/fj.04-3284com.
- Background: PubMed 29766504Wanibuchi K, Hosoda K, Ihara M, Tajiri K, Sakai Y, Masui H, Takahashi T, Hirai Y, Shimomura H. Indene Compounds Synthetically Derived from Vitamin D Have Selective Antibacterial Action on Helicobacter pylori. Lipids. 2018 Apr;53(4):393-401. doi: 10.1002/lipd.12043. Epub 2018 May 16.
- Background: PubMed 26935876Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. 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. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.
- Background: PubMed 20624992Hori Y, Imanishi A, Matsukawa J, Tsukimi Y, Nishida H, Arikawa Y, Hirase K, Kajino M, Inatomi N. 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. J Pharmacol Exp Ther. 2010 Oct;335(1):231-8. doi: 10.1124/jpet.110.170274. Epub 2010 Jul 12.
- Background: PubMed 30038469Iannone A, Giorgio F, Russo F, Riezzo G, Girardi B, Pricci M, Palmer SC, Barone M, Principi M, Strippoli GF, Di Leo A, Ierardi E. New fecal test for non-invasive Helicobacter pylori detection: A diagnostic accuracy study. World J Gastroenterol. 2018 Jul 21;24(27):3021-3029. doi: 10.3748/wjg.v24.i27.3021.
- Background: PubMed 15044704Schreiber S, Konradt M, Groll C, Scheid P, Hanauer G, Werling HO, Josenhans C, Suerbaum S. The spatial orientation of Helicobacter pylori in the gastric mucus. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):5024-9. doi: 10.1073/pnas.0308386101. Epub 2004 Mar 25.
- Background: PubMed 18402185Ceylan A, Kirimi E, Tuncer O, Turkdogan K, Ariyuca S, Ceylan N. Prevalence of Helicobacter pylori in children and their family members in a district in Turkey. J Health Popul Nutr. 2007 Dec;25(4):422-7.
- Individual participant dataSharing planned: No
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Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vonoparazan, Vitamin D and Probiotic in people with HELICOBACTER PYLORI INFECTIONS and Helicobacter Infection, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hagar Khaled Dewidar, Msc in Clinical Pharmacy (+201014679670, hagar.dewidar@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of H pylori eradication difference among the three intervention groups through stool antigen test 4 weeks after completion of therapy. (time frame: 4 weeks after completion of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07293910, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.