Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Helicobacter Pylori Infection Clinical Trial

Official title:

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Multicenter Randomized Clinical Trial of 10 and 14 Days

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04901117
• Other study ID #: 2021-SDU-QILU-G001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2021
• Est. completion date: August 2023

Study information

• Verified date: May 2021
• Source: Shandong University
• Contact: Xiuli Zuo, MD,PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Description:

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1300
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-65.

• Patients with H.pylori infection (Positive for any of the following: H.pylori culture, histopathology test, rapid urease test, 13C/14C-urea breath test, stool H.pylori antigen test).

• Patients whose birth place and residence within five years of birth are Shandong Province.

• Patients who have never received H. pylori eradication treatment.

Exclusion Criteria:

• Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 3 times 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%.

• Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.

• Patients with active gastrointestinal bleeding.

• Patients with a history of upper gastrointestinal surgery.

• Patients allergic to treatment drugs.

• Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks

• Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse

• Patients whose current residence is not in Shandong Province.

• Patients whose re-check 13C/14C-urea breath test is negative before the start of the test.

• Patients who are unwilling or incapable to provide informed consents.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Amoxicillin
Use according to the drug combination options selected by each center.
• Clarithromycin
Use according to the drug combination options selected by each center.
• Tetracycline
Use according to the drug combination options selected by each center.
• Metronidazole
Use according to the drug combination options selected by each center.
• Bismuth Potassium Citrate
Use according to the drug combination options selected by each center.
• Colloidal Bismuth Pectin
Use according to the drug combination options selected by each center.
• Vonoprazan fumarate
Use according to the drug combination options selected by each center.

Locations

Country	Name	City	State
China	Qilu hosipital	Jinan	Shandong

Sponsors (16)

Lead Sponsor

Collaborator

Shandong University

Heze Municipal 3rd people's hospital, Jining No.2 People's Hospital, Maternity and Child Care Health Center of Dezhou, PKUcare luzhong hospital, Qihe County City Hospital, Qilu Hospital of Shandong University, Shandong Electric Power Central Hospital, Shandong Provincial Third Hospital, Taian City Central Hospital, The Affiliated Hospital of Qingdao University, The People's Hospital of Guangrao, Weifang People's Hospital, Weihai Municipal Hospital, Yuncheng Chengxin Hospital, Zoucheng People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Dore MP, Farina V, Cuccu M, Mameli L, Massarelli G, Graham DY. Twice-a-day bismuth-containing quadruple therapy for Helicobacter pylori eradication: a randomized trial of 10 and 14 days. Helicobacter. 2011 Aug;16(4):295-300. doi: 10.1111/j.1523-5378.2011.00857.x. — View Citation

Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27. Review. — View Citation

Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1. — View Citation

Liu WZ, Xie Y, Lu H, Cheng H, Zeng ZR, Zhou LY, Chen Y, Wang JB, Du YQ, Lu NH; Chinese Society of Gastroenterology, Chinese Study Group on Helicobacter pylori and Peptic Ulcer. Fifth Chinese National Consensus Report on the management of Helicobacter pylori infection. Helicobacter. 2018 Apr;23(2):e12475. doi: 10.1111/hel.12475. Epub 2018 Mar 7. — View Citation

Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5. — View Citation

O'Ryan ML, Rabello M, Cortés H, Lucero Y, Peña A, Torres JP. Dynamics of Helicobacter pylori detection in stools during the first 5 years of life in Chile, a rapidly developing country. Pediatr Infect Dis J. 2013 Feb;32(2):99-103. doi: 10.1097/INF.0b013e318278b929. — View Citation

Qiao C, Li Y, Liu J, Ji C, Qu J, Hu J, Ji R, Wan M, Lin B, Lin M, Qi Q, Zuo X, Li Y. Clarithromycin versus furazolidone for naïve Helicobacter pylori infected patients in a high clarithromycin resistance area. J Gastroenterol Hepatol. 2021 Mar 10. doi: 10.1111/jgh.15468. [Epub ahead of print] — View Citation

Rowland M, Daly L, Vaughan M, Higgins A, Bourke B, Drumm B. Age-specific incidence of Helicobacter pylori. Gastroenterology. 2006 Jan;130(1):65-72; quiz 211. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate	Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.	Immediately after follow-up check.
Secondary	Rate of adverse reactions	Rate of adverse reactions	Immediately after follow-up check.
Secondary	Patient compliance	Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.	Immediately after follow-up check.
Secondary	Cost-effectiveness index	Ratio of costs to effectiveness	Immediately after follow-up check.