Optimized Bismuth Quadruple Therapy vs Triple Standard Therapy for Helicobacter Pylori Eradication

NCT05664685 | Completed Phase 4 DMC

• 1 other identifier: 220710002
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 2

Brief Summary

This study have as primary aim "To compare the H. pylori eradication rate between the quadruple bismuth therapy versus the standard triple therapy recommended by the AUGE Clinical Guidelines for Helicobacter pylori eradication treatment in peptic ulcer patients." Briefly, this is a randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists of omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, which consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori erradication

  Determined by Urea breath test for Helicobacter pylori

  8-12 weeks after treatment is ended

Secondary Outcomes (3)

• Incidence of Adverse Drug Reactions

  Day 7, 14 and 21 after treatment begins

• Prevalence of Helicobacter pylori antibiotic resistance to Clarithromycin

  Samples taken at the recruitment

• Prevalence of Host CYP2C19 polymorphisms determination

  Samples taken at the recruitment

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will be treated with Esomeprazole 40 mg every 8 hours, Amoxicillin 1 gr every 8 hours, Metronidazole 500 mg every 8 hours, Bismuth subsalicylate 369 mg every 8 hours.

Drug: Optimized bismuth quadruple therapy

Control

ACTIVE COMPARATOR

The control group will be treated with Omeprazole 20mg every 12 hours, Amoxicillin 1 gr every 12 hours, Clarithromycin 500 mg every 12 hours, Placebo identical to Bismuth Subsalicylate, 3 times daily.

Drug: Control

Interventions

Optimized bismuth quadruple therapy DRUG

Scheme that have high dosage of amoxicillin, metronidazole and omeprazole, with bismuth. The rationale of this scheme is that in Chile, amoxicillin resistance is low, clinical metronidazole is low in the doses used and the high doses ob Proton Pump Inhibitor enhanced the antimicrobial drugs

Also known as: Rama Intervención

Intervention

Control DRUG

Standard eradication therapy using omeprazole, clarithromycin and amoxicillin

Also known as: Rama Control

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with H. pylori infection by positive Urease test.

You may not qualify if:

• Pregnant or lactating women.
• Allergy or history of adverse reaction to the following medications:
• Penicillin
• Salicylate allergy
• Omeprazole
• Has received H. pylori eradication therapy prior to the study.
• Has used PPIs 14 day prior to diagnostic testing
• Use of antibiotics within 4 weeks beforehand.
• History of gastrointestinal bleeding for the last 12 weeks.
• History of partial gastrectomy due to Gastric Cancer
• History of incipient Gastric Cancer resolved by endoscopic resection.
• History of bariatric surgery.
• Serious or malignant diseases with less than 1 year life expectancy.
• History of Clostridium difficile infection.
• History of inflammatory bowel disease.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (2)

Centro de especialidades médicas Marcoleta UC CHRISTUS

Santiago, Santiago Metropolitan, Chile

Location

Centro Médico UC-CHRISTUS San Joaquín

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (22)

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• Medel-Jara PA, Latorre G, Fuentes-Lopez E, Pizarro M, Viviani P, Chahuan J, Maquilon S, Corsi O, Reyes D, Espino A, Vargas JI, Wichmann IA, Harris P, Serrano C, Buruato I, Sandoval C, Varela NM, Cerpa L, Quinones L, Megraud F, Huang RJ, Shah SC, Perez AR. Comparison between optimized bismuth quadruple therapy and standard clarithromycin-based triple therapy for first-line Helicobacter pylori eradication: a double-blind randomized controlled trial. Lancet Reg Health Am. 2025 Nov 22;53:101312. doi: 10.1016/j.lana.2025.101312. eCollection 2026 Jan.

  PMID: 41362749 DERIVED

Study Officials

• Patricio Medel, MPH

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: For the anonymization of the sequence, the research team will delegate the generation of the random sequence and the numbering of the containers to a team that has no participation or knowledge of the design of the study, the collection or analysis of data. The research team will deliver 204 containers with the intervention or control (102 of each) to 1 member of the UC Pharmacology and Toxicology Program. They will generate the randomization sequence, number the containers according to their result and keep the record of the randomization sequence until the data collection is finished, and the statistical analysis is done then the blind opens.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists in omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, that consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: December 27, 2022
• Study Start: October 17, 2022
• Primary Completion: October 30, 2023
• Study Completion: January 30, 2024
• Last Updated: April 12, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)