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

NCT04901117 | Unknown Phase 4

• 1 other identifier: 2021-SDU-QILU-G001
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Bismuth-containing quadruple regimen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of adverse reactions

  Immediately after follow-up check.

• Patient compliance

  Immediately after follow-up check.

• Cost-effectiveness index

  Immediately after follow-up check.

Study Arms (2)

10-day treatment group

EXPERIMENTAL

Use the following drug combination option for 10 days. 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. The dosage of each drug is: Amoxicillin (Amoxicillin, United Laboratories Co., Ltd.) 1000mg bid Clarithromycin (Klacid, Abbott S.r.l) 500mg bid Tetracycline 500mg qid Metronidazole400mg qid Bismuth Potassium Citrate (Livzon Pharmaceutical Group Inc.) 220mg bid Colloidal Bismuth Pectin (North China Pharmaceutical Co., Ltd.) 200mg bid Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid

Drug: Amoxicillin; Drug: Clarithromycin; Drug: Tetracycline; Drug: Metronidazole; Drug: Bismuth Potassium Citrate; Drug: Colloidal Bismuth Pectin; Drug: Vonoprazan fumarate

14-day treatment group

ACTIVE COMPARATOR

Use the following drug combination option for 14 days. 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. The dosage of each drug is: Amoxicillin (Amoxicillin, United Laboratories Co., Ltd.) 1000mg bid Clarithromycin (Klacid, Abbott S.r.l) 500mg bid Tetracycline 500mg qid Metronidazole400mg qid Bismuth Potassium Citrate (Livzon Pharmaceutical Group Inc.) 220mg bid Colloidal Bismuth Pectin (North China Pharmaceutical Co., Ltd.) 200mg bid Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid

Drug: Amoxicillin; Drug: Clarithromycin; Drug: Tetracycline; Drug: Metronidazole; Drug: Bismuth Potassium Citrate; Drug: Colloidal Bismuth Pectin; Drug: Vonoprazan fumarate

Interventions

Amoxicillin DRUG

Use according to the drug combination options selected by each center.

10-day treatment group; 14-day treatment group

Clarithromycin DRUG

Use according to the drug combination options selected by each center.

10-day treatment group; 14-day treatment group

Tetracycline DRUG

Use according to the drug combination options selected by each center.

10-day treatment group; 14-day treatment group

Metronidazole DRUG

Use according to the drug combination options selected by each center.

10-day treatment group; 14-day treatment group

Bismuth Potassium Citrate DRUG

Use according to the drug combination options selected by each center.

10-day treatment group; 14-day treatment group

Colloidal Bismuth Pectin DRUG

Use according to the drug combination options selected by each center.

10-day treatment group; 14-day treatment group

Vonoprazan fumarate DRUG

Use according to the drug combination options selected by each center.

10-day treatment group; 14-day treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead
• The Affiliated Hospital of Qingdao University: collaborator
• The People's Hospital of Guangrao: collaborator
• Weihai Municipal Hospital: collaborator
• Shandong Province Third hospital: collaborator
• Taian City Central Hospital: collaborator
• Jining No.2 People's Hospital: collaborator
• Maternity and Child Care Health Center of Dezhou: collaborator
• Zoucheng People's Hospital: collaborator
• Heze Municipal 3rd people's hospital: collaborator
• Yuncheng Chengxin Hospital: collaborator
• Peking University Care Luzhong Hospital: collaborator
• Qihe County City Hospital: collaborator
• Weifang People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Shandong Electric Power Central Hospital: collaborator

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 257000, China

Location

Related Publications (8)

• 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.

  PMID: 28456631 BACKGROUND

• 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.

  PMID: 29512258 BACKGROUND

• 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.

  PMID: 27707777 BACKGROUND

• 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.

  PMID: 33004546 BACKGROUND

• 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.

  PMID: 21762269 BACKGROUND

• 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. doi: 10.1053/j.gastro.2005.11.004.

  PMID: 16401469 BACKGROUND

• O'Ryan ML, Rabello M, Cortes H, Lucero Y, Pena 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.

  PMID: 23076385 BACKGROUND

• 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 naive Helicobacter pylori infected patients in a high clarithromycin resistance area. J Gastroenterol Hepatol. 2021 Sep;36(9):2383-2388. doi: 10.1111/jgh.15468. Epub 2021 Mar 10.

  PMID: 33691344 BACKGROUND

MeSH Terms

Interventions

Amoxicillin; Clarithromycin; Tetracycline; Metronidazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

15588818685; zuoxiuli@sina.com

Xiuli Zuo, MD,PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Qilu Hospital gastroenterology department

Model Details: This trial is a multi-center, open-label, non-inferiority, randomized controlled trial.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 25, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

CN (1)