Clinical trial NCT06299605: Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori
Official title: Triple Versus Quadruple Therapy with Amoxicillin and Tetracycline for the Eradication of Helicobacter Pylori: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Binzhou Maternal and Child Health Hospital
name: Zibo Maternal and Child Health Hospital
name: Zaozhuang Municipal Hospital
name: Linyi Yizhou Hospital
name: Feicheng Municipal People's Hospital
First posted: 2024-03-08
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eradication rate
timeFrame: Immediately after follow-up check
Secondary outcomes:
measure: Rate of adverse reactions
timeFrame: Immediately after follow-up check
measure: Patient compliance
timeFrame: Immediately after follow-up check
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
citation: 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.
citation: Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.