Clinical trial NCT05649540: Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori
Official title: Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
dual therapy
eradication rate
safety
microbiota
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 900
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 purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Detailed description: This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.

Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.

Eligibility criteria: Inclusion Criteria:

1. Ages between 18 and 70 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria:

1. allergic reactions to the study drugs;
2. patients with peptic ulcer;
3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. patients who have history of esophageal or gastric surgery;
7. pregnant or lactating women;
8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
9. Alcohol abusers
10. MALT lymphoma of stomach or malignant tumor

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: four to eight weeks after completion of the medication
Secondary outcomes:
measure: Adverse event
timeFrame: Within 7 days after completion of therapy
measure: Compliance Rate
timeFrame: Within 7 days after completion of therapy
measure: Microbiota influence
timeFrame: baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy
Other outcomes:
Locations:
city: Changshu
country: China
facility: Changshu No.1 People's Hospital
state: Jiangsu
city: Changzhou
country: China
facility: Changzhou Traditional Chinese Medicine Hospital
state: Jiangsu
city: Lianyungang
country: China
facility: The first people's hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital on Integration of Chinese and Western Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangbei Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Sir Run Run Hospital, Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Taixing
country: China
facility: Taixing People's Hospital
state: Jiangsu
city: Taizhou
country: China
facility: The Fourth People's Hospital of Taizhou
state: Jiangsu
city: Xuzhou
country: China
facility: The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Affiliated Hospital of Yangzhou University
state: Jiangsu
city: Zhangjiagang
country: China
facility: The Affiliated Zhangjiagang Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Zhenyu Zhang
role: STUDY_CHAIR
References:
citation: Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.
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: Ford AC, Malfertheiner P, Giguere M, Santana J, Khan M, Moayyedi P. Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis. World J Gastroenterol. 2008 Dec 28;14(48):7361-70. doi: 10.3748/wjg.14.7361.
citation: Gao CP, Zhang D, Zhang T, Wang JX, Han SX, Graham DY, Lu H. PPI-amoxicillin dual therapy for Helicobacter pylori infection: An update based on a systematic review and meta-analysis. Helicobacter. 2020 Aug;25(4):e12692. doi: 10.1111/hel.12692. Epub 2020 Apr 20.
citation: Furuta T, Shirai N, Kodaira M, Sugimoto M, Nogaki A, Kuriyama S, Iwaizumi M, Yamade M, Terakawa I, Ohashi K, Ishizaki T, Hishida A. Pharmacogenomics-based tailored versus standard therapeutic regimen for eradication of H. pylori. Clin Pharmacol Ther. 2007 Apr;81(4):521-8. doi: 10.1038/sj.clpt.6100043. Epub 2007 Jan 10.
citation: Guan JL, Hu YL, An P, He Q, Long H, Zhou L, Chen ZF, Xiong JG, Wu SS, Ding XW, Luo HS, Li PY. Comparison of high-dose dual therapy with bismuth-containing quadruple therapy in Helicobacter pylori-infected treatment-naive patients: An open-label, multicenter, randomized controlled trial. Pharmacotherapy. 2022 Mar;42(3):224-232. doi: 10.1002/phar.2662. Epub 2022 Feb 5.