Helicobacter Pylori InfectionPhase 4HP-THERAPY-TRINCT07312721
Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis
A Phase 4 study testing Triple Therapy and Quadruple Therapy in people with Helicobacter Pylori Infection and Chronic Gastritis, run by Azfar Farogh at 1 site in Pakistan.
Trial summary
This randomized controlled trial is designed to compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy for the eradication of Helicobacter pylori-induced gastritis. The study is being conducted at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients with confirmed H. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection, Chronic Gastritis, Peptic Ulcer Disease
- What is being tested?
- Triple Therapy and Quadruple Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2024to 30 Dec 2024
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Confirmed Helicobacter pylori infection based on a positive stool antigen test.
- Willing and able to provide written informed consent.
Who cannot join
- History of allergy or hypersensitivity to any of the study drugs (omeprazole, amoxicillin, clarithromycin, metronidazole, tetracycline, or bismuth compounds).
- Prior H. pylori eradication therapy.
- Pregnancy or lactation.
- History of gastrointestinal bleeding, peptic ulcer perforation, or prior gastric surgery.
- Chronic renal failure or hepatic dysfunction.
- Current use of proton pump inhibitors or antibiotics within the previous six weeks.
Show all 9Show fewer
- Use of traditional (Hakeem) medications or herbal remedies affecting gastric function.
- Psychiatric illness or inability to comply with treatment and follow-up.
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shahida Islam Medical College, Lodhran
Lodhran, Punjab Province, 59320
About this study
Official title: Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis: A Randomized Controlled Trial
This randomized controlled trial is designed to compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy for the eradication of Helicobacter pylori-induced gastritis. The study is being conducted at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients with confirmed H. pylori infection are randomly allocated to receive either a 14-day triple therapy regimen or a 14-day bismuth-based quadruple therapy regimen. Eradication of H. pylori is assessed six weeks after completion of treatment using stool antigen testing. The primary outcome measure is the proportion of patients achieving successful eradication of H. pylori.
Read the detailed description
Background:
Helicobacter pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric malignancy. Standard triple therapy has historically been used as first-line treatment; however, increasing antibiotic resistance has led to declining eradication rates in many regions. Bismuth-based quadruple therapy has emerged as an alternative regimen and is recommended in areas with suspected or confirmed antibiotic resistance.
Objective:
To compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy in achieving eradication of Helicobacter pylori in adult patients with H. pylori-induced gastritis.
Study Design and Methods:
This is a randomized controlled trial conducted in the Department of Medicine at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients aged 18 to 65 years with confirmed H. pylori infection based on stool antigen testing are eligible for inclusion. Participants are randomly assigned in a 1:1 ratio to one of two treatment groups. One group receives standard triple therapy consisting of omeprazole, amoxicillin, and clarithromycin for 14 days. The second group receives bismuth-based quadruple therapy consisting of omeprazole, metronidazole, tetracycline, and bismuth subsalicylate for 14 days.
Patients are followed for six weeks after completion of therapy. Eradication of H. pylori is evaluated using repeat stool antigen testing. The primary outcome measure is successful eradication of H. pylori. Secondary analyses include assessment of eradication outcomes across demographic and clinical subgroups.
Ethical Approval:
The study protocol has been approved by the Institutional Review Board of Shahida Islam Medical College (IRB No. SIMC/ETC/0008/24, dated 05 January 2024). Written informed consent is obtained from all participants prior to enrollment.
- Being tested
- Triple Therapy, Quadruple Therapy
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple TherapyDrug
Omeprazole 40 mg BID, Amoxicillin 1 g BID, Clarithromycin 500 mg BID for 14 days.
Quadruple TherapyDrug
Omeprazole 40 mg BID, Metronidazole 400 mg TID, Tetracycline 500 mg QID, Bismuth subsalicylate for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Triple Therapy Group | Experimental | Participants received Omeprazole 40 mg twice daily, Amoxicillin 1 g twice daily, and Clarithromycin 500 mg twice daily for 14 days. Receives: Drug: Triple Therapy |
| Quadruple Therapy Group | Experimental | Participants received Omeprazole 40 mg twice daily, Metronidazole 400 mg three times daily, Tetracycline 500 mg every six hours, and Bismuth subsalicylate for 14 days. Receives: Drug: Quadruple Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Helicobacter pylori infection six weeks post-treatment
Eradication was assessed by stool antigen testing six weeks after completion of therapy. A negative stool antigen test indicated successful eradication.
Measured: 6 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start5 Jan 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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 Pylori InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azfar Farogh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Azfar Farogh, Shahida Islam Medical Complex
- Investigators
- Prof. Dr. Azfar Farogh, Principal investigator, Shahida Islam Medical College, Lodhran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312721
- Sponsor's protocol ID
- SIMC/ETC/0008/24
- Acronym
- HP-THERAPY-TRI
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miao R, Chen J, Gao S, Wang L, Zhou W, Wan C, Wang Z. A randomised controlled clinical study of standard triple therapy, bismuth-based quadruple therapy and sequential therapy for Helicobacter pylori infection in children. BMC Pediatr. 2024 Aug 23;24(1):543. doi: 10.1186/s12887-024-05020-6.
PubMed 39180014
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07312721
- Acronym / sponsor ID
- HP-THERAPY-TRI / SIMC/ETC/0008/24
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- Azfar FaroghUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 31 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.
This randomized controlled trial is designed to compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy for the eradication of Helicobacter pylori-induced gastritis. The study is being conducted at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients with confirmed H. pylori infection are randomly allocated to receive either a 14-day triple therapy regimen or a 14-day bismuth-based quadruple therapy regimen. Eradication of H. pylori is assessed six weeks after completion of treatment using stool antigen testing. The primary outcome measure is the proportion of patients achieving successful eradication of H. pylori.
Detailed description
Background:
Helicobacter pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric malignancy. Standard triple therapy has historically been used as first-line treatment; however, increasing antibiotic resistance has led to declining eradication rates in many regions. Bismuth-based quadruple therapy has emerged as an alternative regimen and is recommended in areas with suspected or confirmed antibiotic resistance.
Objective:
To compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy in achieving eradication of Helicobacter pylori in adult patients with H. pylori-induced gastritis.
Study Design and Methods:
This is a randomized controlled trial conducted in the Department of Medicine at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients aged 18 to 65 years with confirmed H. pylori infection based on stool antigen testing are eligible for inclusion. Participants are randomly assigned in a 1:1 ratio to one of two treatment groups. One group receives standard triple therapy consisting of omeprazole, amoxicillin, and clarithromycin for 14 days. The second group receives bismuth-based quadruple therapy consisting of omeprazole, metronidazole, tetracycline, and bismuth subsalicylate for 14 days.
Patients are followed for six weeks after completion of therapy. Eradication of H. pylori is evaluated using repeat stool antigen testing. The primary outcome measure is successful eradication of H. pylori. Secondary analyses include assessment of eradication outcomes across demographic and clinical subgroups.
Ethical Approval:
The study protocol has been approved by the Institutional Review Board of Shahida Islam Medical College (IRB No. SIMC/ETC/0008/24, dated 05 January 2024). Written informed consent is obtained from all participants prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple Therapy Group | Experimental | Drug: Triple TherapyParticipants received Omeprazole 40 mg twice daily, Amoxicillin 1 g twice daily, and Clarithromycin 500 mg twice daily for 14 days. |
| Quadruple Therapy Group | Experimental | Drug: Quadruple TherapyParticipants received Omeprazole 40 mg twice daily, Metronidazole 400 mg three times daily, Tetracycline 500 mg every six hours, and Bismuth subsalicylate for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65 years.
- Confirmed Helicobacter pylori infection based on a positive stool antigen test.
- Willing and able to provide written informed consent.
Key exclusion criteria (9 listed)
- History of allergy or hypersensitivity to any of the study drugs (omeprazole, amoxicillin, clarithromycin, metronidazole, tetracycline, or bismuth compounds).
- Prior H. pylori eradication therapy.
- Pregnancy or lactation.
- History of gastrointestinal bleeding, peptic ulcer perforation, or prior gastric surgery.
- Chronic renal failure or hepatic dysfunction.
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 |
|---|---|---|
| Triple TherapyOmeprazole 40 mg BID, Amoxicillin 1 g BID, Clarithromycin 500 mg BID for 14 days. | Drug | Triple Therapy Group |
| Quadruple TherapyOmeprazole 40 mg BID, Metronidazole 400 mg TID, Tetracycline 500 mg QID, Bismuth subsalicylate for 14 days. | Drug | Quadruple Therapy Group |
Primary outcome
Eradication of Helicobacter pylori infection six weeks post-treatment
Time frame: 6 weeks after treatment completion
Eradication was assessed by stool antigen testing six weeks after completion of therapy. A negative stool antigen test indicated successful eradication.
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 31 Dec 2025.
- Results publication: PubMed 39180014Miao R, Chen J, Gao S, Wang L, Zhou W, Wan C, Wang Z. A randomised controlled clinical study of standard triple therapy, bismuth-based quadruple therapy and sequential therapy for Helicobacter pylori infection in children. BMC Pediatr. 2024 Aug 23;24(1):543. doi: 10.1186/s12887-024-05020-6.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
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. This study is not recruiting at the moment.
Prof. Dr. Azfar Farogh principal investigator
Shahida Islam Medical College, Lodhran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triple Therapy and Quadruple Therapy in people with Helicobacter Pylori Infection and Chronic Gastritis, run by Azfar Farogh at 1 site in Pakistan.
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 3 inclusion and 9 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 31 Dec 2025. 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Eradication of Helicobacter pylori infection six weeks post-treatment (time frame: 6 weeks after treatment completion). 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 NCT07312721, 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 31 Dec 2025.