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Enrolling by invitationNCT07010744Updated May 7, 2026

Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection

An interventional study of Triple drug regimen and Quadruple therapy in Dyspepsia, sponsored by Akil Al Islam. Enrolling by invitation at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Akil Al Islam · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The Goal of this this clinical trial is to assess and compare the eradication rate of triple and quadruple therapy during treating helicobacter pylori infection among patients presented with dyspepsia. It will also assess the patient reported adverse events among two groups.

H pylori infection will be confirmed by CLO (RUT) test and stool antigen test both.

Standard triple therapy will be based on Esomeprazole 20 mg BD, Clarithromycin 500mg BD and Amoxicillin 1gm BD. Bismuth Quadruple therapy consists of Bismuth subcitrate 120mg QDS, Tetracycline 500mg QDS and Metronidazole 500mg TDS. Patient will be confirmed H pylori eradication 4 weeks after completion of treatment by Stool antigen test only.

Read the detailed description

This Randomized Controlled Trial study aims to compare the eradication rates of Helicobacter pylori infection between quadruple therapy and triple therapy in dyspeptic patients at Dhaka Medical College \& Hospital.

Sixty-Six participants, selected through purposive sampling, will be randomly allocated into two groups: 33 patients in Group A (receiving Triple therapy) and 33 in Group B (receiving Quadruple therapy). After pre-procedural preparation, a CLO test will be conducted during endoscopy and a stool antigen test to detect H. pylori. Participants will undergo treatment for 14 days, followed by follow-up testing 6 weeks later to evaluate eradication. Ethical approval will be obtained, and confidentiality will be maintained.

02

Conditions studied

  • Dyspepsia

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03

In context

Dyspepsia

372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.

This study's planned enrollment of 66 is below the median of 89 across 302 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

This is the only study on the registry with Akil Al Islam as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All dyspeptic patients aged ≥18 years.
  • Patients who will provide informed written consent and agree to follow-up at 4 weeks post-treatment.

Exclusion criteria

Exclusion Criteria:

  • Patients who have received prior H. pylori eradication therapy.
  • Ingestion of antibiotics or proton pump inhibitor within the prior 4 weeks. Patient who will test negative either of CLO or Stool Antigen Test or both
  • Patients with known allergies or intolerance to any of the study medications.
  • Patients with alarm symptoms (e.g., unexplained weight loss, persistent vomiting, dysphagia).
  • Patients with a history of gastric surgery.
  • Pregnant or lactating women.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Triple drug Therapy

    Triple drug therapy includes Amoxicillin , clarithromycin and esomeprazole

    Drug: Triple drug regimen

  • Experimental
    Quadruple therapy

    Bismuth Metronidazole Tetracycline Esomeprazole

    Drug: Quadruple therapy

Interventions

  • DrugTriple drug regimen

    Amoxicillin 1000mg at 12 hourly for 14 days Clarithromycin 500mg at 12 hourly for 14 days Esomeprazole 20 mg at 12 hourly for 14 days

  • DrugQuadruple therapy

    Drug pages: Esomeprazole · Metronidazole · Bismuth tripotassium dicitrate · Tetracycline

    Bismuth subcitrate 120 mg at 6 hourly 14 days Metronidazole 500mg at 8 hourly 14 days Tetracycline 500mg at 6 hourly 14 days Esomeprazole 20 mg 12 hourly for 14 days

06

What researchers measure

Primary outcomes

  1. To compare the eradication rate of Helicobacter pylori infection between quadruple therapy and triple therapy among dyspeptic patients

    Time frame: 1 month

Secondary outcomes

  1. 1. To determine the eradication rate of H. pylori in patients receiving triple drug therapy. 2. To determine the eradication rate of H. pylori in patients receiving quadruple therapy. 3. Assess and quantify patient reported adverse events in both groups

    Time frame: 1 month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — I shall decide it later

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07010744
Lead sponsor
Akil Al Islam
Responsible party
Akil Al Islam (Principal Investigator, Dhaka Medical College) — Sponsor-investigator
First posted
Jun 8, 2025
Start date
Jul 1, 2025
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
May 7, 2026

Study contacts

Akil Al Islam, MBBS,MRCP
principal investigator · Dhaka Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Studies of the drugs tested here: Esomeprazole · Metronidazole · Bismuth tripotassium dicitrate · Tetracycline

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