Helicobacter EradicationPhase 3NCT07810985
Bismuth Quadruple Therapy Versus Modified Bismuth Therapy for Helicobacter Pylori
A Phase 3 study testing Bismuth added on triple therapy and Quadruple therapy in people with Helicobacter Eradication, run by Reham Abdelkader Elkhouly at 1 site in Egypt.
Trial summary
The primary objective of the study is to compare the efficacy of 2 different regimens of treatment of gastric bacteria (H pylori) these are: quadruple bismuth therapy and clarithromycin triple therapy with add-on bismuth, in eradicating H. pylori. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Eradication
- What is being tested?
- Bismuth added on triple therapy and Quadruple therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years.
- Confirmed diagnosis of H. pylori infection.
Who cannot join
- Pregnant or lactating women.
- Prior treatment for H. pylori infection.
- History of antibiotic or PPI use within the month preceding enrollment.
- History of hypersensitivity or allergic reaction to any of the study drugs.
- Presence of any contraindication to the study medications.
- Advanced chronic liver disease or renal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eradication of Helicobacter Pylori: A Comparative Randomized Controlled Trial of Bismuth Quadruple Therapy and Bismuth Add-on to Clarithromycin Triple Therapy
The primary objective of the study is to compare the efficacy of 2 different regimens of treatment of gastric bacteria (H pylori) these are: quadruple bismuth therapy and clarithromycin triple therapy with add-on bismuth, in eradicating H. pylori.
The secondary objective of the study is detection of adverse effects and treatment compliance in both regimens.
Read the detailed description
Study Design: Open label randomized controlled trial (RCT). Period of study:From September 2023 to September 2025 Participants: Among patients attending Gastroenterology clinic in Tropical medicine and infectious diseases department-Tanta university;200 patients with a confirmed diagnosis of helicobacter pylori infection were enrolled and allocated randomly in 2 equal parallel treatment arms.
Sample Size Calculation:
The sample size was calculated using a free online clinical trial calculator (ClinCalc.com) based on effect sizes from previous studies. A recent study in KSA reported an eradication rate of 78.3% for bismuth-based quadruple therapy [1]. Conversely, other studies have reported eradication rates of 88-94% [2] and 91.5-97.3% [3] for bismuth-based triple therapy. At a 95% confidence interval (α-error = 0.05) and 80% statistical power (β-error = 0.2), the minimum required sample size was 146 patients, allocated equally (73 per arm) [4]. To account for an anticipated attrition rate of approximately 30% a total of 200 patients (100 per group) were recruited.
Randomization and Allocation:
To ensure unbiased group assignment and concealment of the allocation sequence, a computer-generated randomization scheme was implemented. Block randomization was performed using a block size of 4, with computer-generated random permutations within each block. To minimize the risk of predicting the allocation sequence, the block size was randomly varied using blocks of 4 and 6 and was not disclosed to the treating investigator. Each enrolled patient was assigned a unique numerical identifier. The complete list of patient identifiers was then sorted in ascending order according to the generated random values. Based on this sorted sequence, the first 100 patients were allocated to Group I (Bismuth add on triple therapy), while the remaining 100 patients were assigned to Group II (Bismuth quadruple therapy). To maintain allocation concealment, the randomization sequence was generated by an independent investigator who was not involved in patient enrollment or outcome assessment. Group assignments were placed in sequentially numbered, opaque, sealed envelopes, which were opened just before starting treatment and after the enrolling physician confirmed patient eligibility and obtained written his/her informed consent.
All patients in the study will be subjected to the following:
Full history taking. Complete clinical examination. Laboratory Investigations including: complete blood picture, liver function tests and renal function tests.
Abdominal ultrasound. Confirm ation of H.pylori infection with either: quantification of H. pylori antigen in stool by ELISA, r upper gastrointestinal endoscopic biopsy and histopathological examination.
- Conditions
- Helicobacter Eradication
- Being tested
- Bismuth added on triple therapy, Quadruple therapy
- Keywords
- BQT, Bismith, H pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth added on triple therapyDrug
Also called modified bismuth quadruple therapy
A 14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Clarithromycin (500 mg twice daily), Amoxicillin (1 g twice daily), and the proton pump inhibitor (PPI) Esomeprazole (40 mg twice daily).
Quadruple therapyDrug
Also called BQT
14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Doxycycline (100 mg twice daily), Metronidazole (500 mg three times daily), and Esomeprazole (40 mg twice daily).
| Study group | Role | What they receive |
|---|---|---|
| Bismuth added on triple therapy | Experimental | 100 patients received oral triple therapy with add-on bismuth in the form of (Bismuth subcitrate 240 mg twice daily, Clarithromycin 500 mg twice daily, Amoxicillin 1gm twice daily, (PPI) Esomeprazole 40 mg twice daily for 2 weeks). Receives: Drug: Bismuth added on triple therapy |
| bismuth quadruple therapy | Active comparator | 100 patients received 14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Doxycycline (100 mg twice daily), Metronidazole (500 mg three times daily), and Esomeprazole (40 mg twice daily). Receives: Drug: Quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
cure rate in the experimental arm compared with cure rate in the comparator arm
Measured: 4 weeks after the end of therapy
Secondary outcomes (1)
adverse events
adverse events of the two regimens in the two arms
Measured: throughout the14 days of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2023
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter EradicationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Abdelkader Elkhouly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Abdelkader Elkhouly, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810985
- Sponsor's protocol ID
- 36265MD120/8/23
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for patients confidentiality
Publications
1)Awuku YA, Simpong DL, Alhassan IK, Tuoyire DA, et al (2017): Prevalence of Helicobacter pylori infection among children living in a rural setting in subSaharan Africa. BMC Public Health.17:360 2) Alhammad M.A.a, El-Kady H.b, Hamed Y.c. (2019): Clarithromycin resistance and genetic pattern of Helicobacter pylori in a group of patients with peptic ulcer disease in Alexandria, Egypt. International Journal of scientific and technology research. 8, Issue 3,149-159 3) Alsohaibani F, Alquaiz M, Alkahtani K, et al (2020): Efficacy of a bismuth-based quadruple therapy regimen for Helicobacter pylori eradication in Saudi Arabia.Saudi Journal of Gastroenterology. 26-2 4) Chey W.D, Leontiadis G.I, Howden C.W, et al (2017): ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol .112:212-238 5) Fagoonee, S and Pellicano, R. (2019): Helicobacter pylori: Molecular basis for colonization and survival in gastric environment and resistance to antibiotics. A short review. Infect. Dis. 51, 399-408 6)Georgopoulos.s and Papastergiou.v (2021):An update on current and advancing pharmacotherapy options for the treatment of H. pylori infection Expert Opinion on Pharmacotherapy .Volume 22- Issue 6. 7) Ghaith.D, Elzahry.M, Mostafa.G, et al (2016): Mutations affecting domain V of the 23S rRNA gene in Helicobacter pylori from Cairo, Egypt. J Chemother. 28(5):367-370 8) Isaeva, G.S and Fagoonee, S (2018): Biological properties and pathogenicity factors of Helicobacter pylori. Minerva Gastroenterol. Dietol. 64, 255-266 9).KaneS.P(2019):SampleSizeCalculatorClinCalc:https://clincalc.com/stats/samplesize.aspx. Updated July 24, 2019. Accessed July 16, 2023. 10) Liao J, Zheng Q, Liang X, et al (2013): Effect of fluoroquinolone resistance on 14-day levofloxacin triple and triple plus bismuth quadruple therapy. Helicobacter.18:373-377. 11) McNicholl A.G, Bordin D.s, Lucendo.A(2020): Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter pylori Infec
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eradication of Helicobacter Pylori: A Comparative Randomized Controlled Trial of Bismuth Quadruple Therapy and Bismuth Add-on to Clarithromycin Triple Therapy
- ClinicalTrials.gov ID
- NCT07810985
- Acronym / sponsor ID
- 36265MD120/8/23
- Conditions
- Helicobacter Eradication
- Keywords
- BQT, Bismith, H pylori
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Reham Abdelkader ElkhoulyUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Sep 2026 (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.
The primary objective of the study is to compare the efficacy of 2 different regimens of treatment of gastric bacteria (H pylori) these are: quadruple bismuth therapy and clarithromycin triple therapy with add-on bismuth, in eradicating H. pylori.
The secondary objective of the study is detection of adverse effects and treatment compliance in both regimens.
Detailed description
Study Design: Open label randomized controlled trial (RCT). Period of study:From September 2023 to September 2025 Participants: Among patients attending Gastroenterology clinic in Tropical medicine and infectious diseases department-Tanta university;200 patients with a confirmed diagnosis of helicobacter pylori infection were enrolled and allocated randomly in 2 equal parallel treatment arms.
Sample Size Calculation:
The sample size was calculated using a free online clinical trial calculator (ClinCalc.com) based on effect sizes from previous studies. A recent study in KSA reported an eradication rate of 78.3% for bismuth-based quadruple therapy [1]. Conversely, other studies have reported eradication rates of 88-94% [2] and 91.5-97.3% [3] for bismuth-based triple therapy. At a 95% confidence interval (α-error = 0.05) and 80% statistical power (β-error = 0.2), the minimum required sample size was 146 patients, allocated equally (73 per arm) [4]. To account for an anticipated attrition rate of approximately 30% a total of 200 patients (100 per group) were recruited.
Randomization and Allocation:
To ensure unbiased group assignment and concealment of the allocation sequence, a computer-generated randomization scheme was implemented. Block randomization was performed using a block size of 4, with computer-generated random permutations within each block. To minimize the risk of predicting the allocation sequence, the block size was randomly varied using blocks of 4 and 6 and was not disclosed to the treating investigator. Each enrolled patient was assigned a unique numerical identifier. The complete list of patient identifiers was then sorted in ascending order according to the generated random values. Based on this sorted sequence, the first 100 patients were allocated to Group I (Bismuth add on triple therapy), while the remaining 100 patients were assigned to Group II (Bismuth quadruple therapy). To maintain allocation concealment, the randomization sequence was generated by an independent investigator who was not involved in patient enrollment or outcome assessment. Group assignments were placed in sequentially numbered, opaque, sealed envelopes, which were opened just before starting treatment and after the enrolling physician confirmed patient eligibility and obtained written his/her informed consent.
All patients in the study will be subjected to the following:
Full history taking. Complete clinical examination. Laboratory Investigations including: complete blood picture, liver function tests and renal function tests.
Abdominal ultrasound. Confirm ation of H.pylori infection with either: quantification of H. pylori antigen in stool by ELISA, r upper gastrointestinal endoscopic biopsy and histopathological examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bismuth added on triple therapy | Experimental | Drug: Bismuth added on triple therapy100 patients received oral triple therapy with add-on bismuth in the form of (Bismuth subcitrate 240 mg twice daily, Clarithromycin 500 mg twice daily, Amoxicillin 1gm twice daily, (PPI) Esomeprazole 40 mg twice daily for 2 weeks). |
| bismuth quadruple therapy | Active comparator | Drug: Quadruple therapy100 patients received 14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Doxycycline (100 mg twice daily), Metronidazole (500 mg three times daily), and Esomeprazole (40 mg twice daily). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥ 18 years.
- Confirmed diagnosis of H. pylori infection.
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- Prior treatment for H. pylori infection.
- History of antibiotic or PPI use within the month preceding enrollment.
- History of hypersensitivity or allergic reaction to any of the study drugs.
- Presence of any contraindication to the study medications.
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 |
|---|---|---|
| Bismuth added on triple therapyAlso: modified bismuth quadruple therapyA 14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Clarithromycin (500 mg twice daily), Amoxicillin (1 g twice daily), and the proton pump inhibitor (PPI) Esomeprazole (40 mg twice daily). | Drug | Bismuth added on triple therapy |
| Quadruple therapyAlso: BQT14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Doxycycline (100 mg twice daily), Metronidazole (500 mg three times daily), and Esomeprazole (40 mg twice daily). | Drug | bismuth quadruple therapy |
Primary outcome
cure rate
Time frame: 4 weeks after the end of therapy
cure rate in the experimental arm compared with cure rate in the comparator arm
1 secondary outcome
adverse events
Time frame: throughout the14 days of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background1)Awuku YA, Simpong DL, Alhassan IK, Tuoyire DA, et al (2017): Prevalence of Helicobacter pylori infection among children living in a rural setting in subSaharan Africa. BMC Public Health.17:360 2) Alhammad M.A.a, El-Kady H.b, Hamed Y.c. (2019): Clarithromycin resistance and genetic pattern of Helicobacter pylori in a group of patients with peptic ulcer disease in Alexandria, Egypt. International Journal of scientific and technology research. 8, Issue 3,149-159 3) Alsohaibani F, Alquaiz M, Alkahtani K, et al (2020): Efficacy of a bismuth-based quadruple therapy regimen for Helicobacter pylori eradication in Saudi Arabia.Saudi Journal of Gastroenterology. 26-2 4) Chey W.D, Leontiadis G.I, Howden C.W, et al (2017): ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol .112:212-238 5) Fagoonee, S and Pellicano, R. (2019): Helicobacter pylori: Molecular basis for colonization and survival in gastric environment and resistance to antibiotics. A short review. Infect. Dis. 51, 399-408 6)Georgopoulos.s and Papastergiou.v (2021):An update on current and advancing pharmacotherapy options for the treatment of H. pylori infection Expert Opinion on Pharmacotherapy .Volume 22- Issue 6. 7) Ghaith.D, Elzahry.M, Mostafa.G, et al (2016): Mutations affecting domain V of the 23S rRNA gene in Helicobacter pylori from Cairo, Egypt. J Chemother. 28(5):367-370 8) Isaeva, G.S and Fagoonee, S (2018): Biological properties and pathogenicity factors of Helicobacter pylori. Minerva Gastroenterol. Dietol. 64, 255-266 9).KaneS.P(2019):SampleSizeCalculatorClinCalc:https://clincalc.com/stats/samplesize.aspx. Updated July 24, 2019. Accessed July 16, 2023. 10) Liao J, Zheng Q, Liang X, et al (2013): Effect of fluoroquinolone resistance on 14-day levofloxacin triple and triple plus bismuth quadruple therapy. Helicobacter.18:373-377. 11) McNicholl A.G, Bordin D.s, Lucendo.A(2020): Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter pylori Infec
- Individual participant dataSharing planned: No. for patients confidentiality
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bismuth added on triple therapy and Quadruple therapy in people with Helicobacter Eradication, run by Reham Abdelkader Elkhouly 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 6 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: finished, as of the sponsor's last update on 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: 4 weeks after the end 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 NCT07810985, which also lists 1 linked publication.
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 11 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.