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Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori

NCT ID: NCT06299605

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-27

Study Completion Date

2025-11-30

Brief Summary

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The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Detailed Description

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H. pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention:

14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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14-day quadruple regimen

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days

Group Type ACTIVE_COMPARATOR

Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days

Intervention Type DRUG

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days

14-day triple regimen

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days

Group Type EXPERIMENTAL

Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days

Intervention Type DRUG

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days

7-day triple regimen

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

Group Type EXPERIMENTAL

Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days

Intervention Type DRUG

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

Interventions

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Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days

Intervention Type DRUG

Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days

Intervention Type DRUG

Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

Intervention Type DRUG

Other Intervention Names

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Vonoprazan Amoxicillin Tetracycline Bismuth 14 days Vonoprazan Amoxicillin Tetracycline 14 days Vonoprazan Amoxicillin Tetracycline 7 days

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18-70 years old;
2. Patients with H.pylori infection (positive rapid urease test, 13C/14C-urea breath test);
3. Patients without previous treatment for H. pylori eradication.

Exclusion Criteria

1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%;
2. Patients with active gastrointestinal bleeding;
3. Patients with a history of upper gastrointestinal surgery;
4. Patients allergic to treatment drugs;
5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks;
6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial;
7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse;
8. Patients who are unwilling or incapable to provide informed consents.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Binzhou Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Zibo Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Zaozhuang Municipal Hospital

OTHER

Sponsor Role collaborator

Linyi Yizhou Hospital

UNKNOWN

Sponsor Role collaborator

Feicheng Municipal People's Hospital

UNKNOWN

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

References

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Li Y, Choi H, Leung K, Jiang F, Graham DY, Leung WK. Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):553-564. doi: 10.1016/S2468-1253(23)00070-5. Epub 2023 Apr 20.

Reference Type BACKGROUND
PMID: 37086739 (View on PubMed)

Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.

Reference Type BACKGROUND
PMID: 30893536 (View on PubMed)

Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Online ahead of print.

Reference Type BACKGROUND
PMID: 35944925 (View on PubMed)

Lin K, Huang L, Wang Y, Li K, Ye Y, Yang S, Li A. Efficacy of genotypic susceptibility-guided tailored therapy for Helicobacter pylori infection: A systematic review and single arm meta-analysis. Helicobacter. 2023 Dec;28(6):e13015. doi: 10.1111/hel.13015. Epub 2023 Aug 27.

Reference Type BACKGROUND
PMID: 37634236 (View on PubMed)

Savoldi A, Carrara E, Graham DY, Conti M, Tacconelli E. Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology. 2018 Nov;155(5):1372-1382.e17. doi: 10.1053/j.gastro.2018.07.007. Epub 2018 Jul 7.

Reference Type BACKGROUND
PMID: 29990487 (View on PubMed)

Jiang Z, Qian X, Wang Z, Dong Y, Pan Y, Zhang Z, Wang S. Antibiotic resistance of Helicobacter pylori isolated from patients in Nanjing, China: A cross-section study from 2018 to 2021. Front Cell Infect Microbiol. 2022 Sep 8;12:970630. doi: 10.3389/fcimb.2022.970630. eCollection 2022.

Reference Type BACKGROUND
PMID: 36159644 (View on PubMed)

Chey WD, Megraud F, Laine L, Lopez LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.

Reference Type BACKGROUND
PMID: 35679950 (View on PubMed)

Xie Y, Hu Y, Zhu Y, Wang H, Wang QZ, Li YQ, Wang JB, Zhang ZY, Zhang DK, Liu XW, Lu NH. Colloidal bismuth pectin-containing quadruple therapy as the first-line treatment of Helicobacter pylori infection: A multicenter, randomized, double-blind, non-inferiority clinical trial. Helicobacter. 2023 Jun;28(3):e12978. doi: 10.1111/hel.12978. Epub 2023 Mar 31.

Reference Type BACKGROUND
PMID: 37002653 (View on PubMed)

Other Identifiers

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SHARE2401

Identifier Type: -

Identifier Source: org_study_id