Optimal Duration of Bismuth Quadruple Therapy for Helicobacter Pylori Eradication in Females As Compared with Males

NCT06509139 | Enrolling By Invitation Phase 4

• 1 other identifier: A-BR-113-029
• Study Type: interventional
• Target: 661
• Locations: 1 country
• Sites: 1

Brief Summary

Helicobacter pylori eradication can reduce the risk of gastric cancer and decrease the recurrence of ulcers. However, in recent years, the increasing antibiotic resistance of Helicobacter pylori has reduced the efficacy of clarithromycin-based triple therapy to below 80%. The recent studies, including real-world data and a clinical trial, have consistently found that females have poorer eradication rate of Helicobacter pylori as compared with males. In previous clinical trial, investigators discovered that the efficacy of a 10-day bismuth quadruple therapy was not inferior to a 14-day bismuth quadruple therapy. However, it remains to be investigated whether the 10-day bismuth quadruple therapy is still non-inferior to the 14-day regimen in females. This project continues the clinical trial to investigate whether the efficacy of the 10-day bismuth quadruple therapy in females is inferior to that in males and whether the 14-day bismuth quadruple therapy is superior to the 10-day regimen in females. The ultimate goal is to establish that male patients can use the 10-day bismuth quadruple therapy with fewer side effects and without compromising efficacy as compared with the 14-day regimen; while female patients are recommended to use the 14-day bismuth quadruple therapy as it would be more effective than the 10-day regimen. Considering sex in research is becoming increasingly important, as females have more antibiotic-resistant Helicobacter pylori infection than males. The bismuth quadruple therapy can overcome most resistance issues. Researching and comparing the difference in the efficacy of bismuth quadruple therapy for Helicobacter pylori eradication between females and males are of significant clinical importance and align with current research trends.

Conditions

Helicobacter Pylori Infection; Sex; Bismuth Quadruple Therapy

Outcome Measures

Primary Outcomes (1)

• The successful eradication rate

  The patients stop taking the proton pump inhibitor and antibiotics for 4 to 6 weeks, and then they receive 13C-urea breath test or an H. pylori stool antigen test to confirm successful eradication or not. The successful rate is represented with a percentage (%).

  About 4 to 6 weeks after receiving the H. pylori eradication regimen

Secondary Outcomes (2)

• Adverse effects of the bismuth-based quadruple therapy

  Since 1st day to 4 weeks after receiving the H. pylori eradication regimen

• Adherence to medications of the bismuth-based quadruple therapy

  Since 1st day to 4 weeks after receiving the H. pylori eradication regimen

Study Arms (3)

The 10-day bismuth-based quadruple therapy group for females

ACTIVE COMPARATOR

The female patients receive a 10-day course of the bismuth-based quadruple therapy, including esomeprazole (Nexium 40 mg) 1 tab twice a day, bismuth subcitrate (dibismuth trioxide) (KCB F.C. 120 mg) 1 tab four times a day, metronidazole (Fuliclin 250 mg) 2 tab thrice a day, and tetracycline (250 mg) 2 tab four times a day.

Drug: Drug: Bismuth Subcitrate 120 MG Oral Tablet; Drug: Esomeprazole 40mg; Drug: Metronidazole 250 MG; Drug: Tetracycline Pill

The 14-day bismuth-based quadruple therapy group for females

ACTIVE COMPARATOR

The female patients receive a 14-day course of the bismuth-based quadruple therapy, including esomeprazole (Nexium 40 mg) 1 tab twice a day, bismuth subcitrate (dibismuth trioxide) (KCB F.C. 120 mg) 1 tab four times a day, metronidazole (Fuliclin 250 mg) 2 tab thrice a day, and tetracycline (250 mg) 2 tab four times a day.

Drug: Drug: Bismuth Subcitrate 120 MG Oral Tablet; Drug: Esomeprazole 40mg; Drug: Metronidazole 250 MG; Drug: Tetracycline Pill

The 10-day bismuth-based quadruple therapy group for males

ACTIVE COMPARATOR

The male patients receive a 10-day course of the bismuth-based quadruple therapy, including esomeprazole (Nexium 40 mg) 1 tab twice a day, bismuth subcitrate (dibismuth trioxide) (KCB F.C. 120 mg) 1 tab four times a day, metronidazole (Fuliclin 250 mg) 2 tab thrice a day, and tetracycline (250 mg) 2 tab four times a day.

Drug: Drug: Bismuth Subcitrate 120 MG Oral Tablet; Drug: Esomeprazole 40mg; Drug: Metronidazole 250 MG; Drug: Tetracycline Pill

Interventions

Drug: Bismuth Subcitrate 120 MG Oral Tablet DRUG

Bismuth Subcitrate (120 MG Oral Tablet) 1 tab per oral four times per day for 14 days in the14-day bismuth-based quadruple therapy and for 10 days in the10-day bismuth-based quadruple therapy

Also known as: KCB F.C.

The 10-day bismuth-based quadruple therapy group for females; The 10-day bismuth-based quadruple therapy group for males; The 14-day bismuth-based quadruple therapy group for females

Esomeprazole 40mg DRUG

Esomeprazole (40 mg) 1 tab per oral twice per day for 14 days in the14-day bismuth-based quadruple therapy and for 10 days in the10-day bismuth-based quadruple therapy

Also known as: Nexium

The 10-day bismuth-based quadruple therapy group for females; The 10-day bismuth-based quadruple therapy group for males; The 14-day bismuth-based quadruple therapy group for females

Metronidazole 250 MG DRUG

Metronidazole (250 MG) 2 tab per oral thrice per day for 14 days in the14-day bismuth-based quadruple therapy and for 10 days in the10-day bismuth-based quadruple therapy

Also known as: Fuliclin

The 10-day bismuth-based quadruple therapy group for females; The 10-day bismuth-based quadruple therapy group for males; The 14-day bismuth-based quadruple therapy group for females

Tetracycline Pill DRUG

Tetracycline (250 MG) 2 tab per oral four times per day for 14 days in the14-day bismuth-based quadruple therapy and for 10 days in the10-day bismuth-based quadruple therapy

Also known as: Tetracycline (250 mg)

The 10-day bismuth-based quadruple therapy group for females; The 10-day bismuth-based quadruple therapy group for males; The 14-day bismuth-based quadruple therapy group for females

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Females and males are defined by biological attributes based on external body characteristics
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are \> 18 years
• H. pylori infection confirmed by histology of a gastric biopsy, a positive rapid urease test, or a positive 13C-urea breath test.

You may not qualify if:

• History of H. pylori eradication
• Previous allergic reactions to any drugs in the bismuth quadruple therapy
• Severe comorbidities
• Pregnant or breastfeeding women

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Helicobacter pylori study group, National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

MeSH Terms

Conditions

Coitus

Interventions

bismuth tripotassium dicitrate; Tablets; Esomeprazole; Metronidazole; Tetracycline

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Hsiu-Chi Cheng, MD, PhD

  Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Among the H. pylori-infected female patients, they are randomized to the 14-day bismuth-based quadruple therapy group and the 10-day bismuth-based quadruple therapy group to receive a 14-day and 10-day course, respectively, of the bismuth-based quadruple therapy. Afterward, the patients stop taking the proton pump inhibitor and antibiotics for 4 to 6 weeks, and then they receive 13C-urea breath test or an H. pylori stool antigen test to confirm successful eradication or not. The study also investigates the efficacy of the 10-day bismuth quadruple therapy between females and males following the above interventional study model.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 19, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): July 31, 2032
• Study Completion (Estimated): July 31, 2032
• Last Updated: November 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)