Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis

NCT07312721 | Completed Phase 4

• 1 other identifier: SIMC/ETC/0008/24
• Study Type: interventional
• Target: 752
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Gastritis; Peptic Ulcer Disease; Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks after treatment completion

Study Arms (2)

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.

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.

Drug: Quadruple Therapy

Interventions

Triple Therapy DRUG

Omeprazole 40 mg BID, Amoxicillin 1 g BID, Clarithromycin 500 mg BID for 14 days.

Triple Therapy Group

Quadruple Therapy DRUG

Omeprazole 40 mg BID, Metronidazole 400 mg TID, Tetracycline 500 mg QID, Bismuth subsalicylate for 14 days.

Quadruple Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years.
• Confirmed Helicobacter pylori infection based on a positive stool antigen test.
• Willing and able to provide written informed consent.

You may not qualify if:

• 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.
• Use of traditional (Hakeem) medications or herbal remedies affecting gastric function.
• Psychiatric illness or inability to comply with treatment and follow-up.

Sponsors & Collaborators

• Azfar Farogh: lead

Study Sites (1)

Shahida Islam Medical College, Lodhran

Lodhran, Punjab Province, 59320, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 39180014 RESULT

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Prof. Dr. Azfar Farogh

  Shahida Islam Medical College, Lodhran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 31, 2025
• Study Start: January 5, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)