Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

NCT05431075 | Completed Phase 4

• 1 other identifier: 2022-SDU-QILU-G004
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 6

Brief Summary

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth 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; tetracycline; 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)

Tid group

EXPERIMENTAL

Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid

Drug: Amoxicillin; Drug: Tetracycline tid; Drug: Bismuth Potassium Citrate; Drug: Colloidal Bismuth Pectin; Drug: Esomeprazole 20mg

Qid group

ACTIVE COMPARATOR

Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid

Drug: Amoxicillin; Drug: Tetracycline qid; Drug: Bismuth Potassium Citrate; Drug: Colloidal Bismuth Pectin; Drug: Esomeprazole 20mg

Interventions

Amoxicillin DRUG

Included in quadruple eradication medication.

Qid group; Tid group

Tetracycline tid DRUG

Included in quadruple eradication medication.

Tid group

Tetracycline qid DRUG

Included in quadruple eradication medication.

Qid group

Bismuth Potassium Citrate DRUG

Included in quadruple eradication medication.

Qid group; Tid group

Colloidal Bismuth Pectin DRUG

Included in quadruple eradication medication.

Qid group; Tid group

Esomeprazole 20mg DRUG

Included in quadruple eradication medication.

Qid group; Tid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70.
• Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
• 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 1.5 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 who are unwilling or incapable to provide informed consents.

Sponsors & Collaborators

• Shandong University: lead
• Peking University Care Luzhong Hospital: collaborator
• Yuncheng Traditional Chinese Medicine Hospital: collaborator
• Taierzhuang District People's Hospital: collaborator
• Zhengzhou Central Hospital: collaborator
• Zibo Central Hospital: collaborator

Study Sites (6)

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Location

Qilu hosipital

Jinan, Shandong, 257000, China

Location

Taierzhuang District People's Hospital

Taierzhuang, Shandong, China

Location

Yuncheng Hospital of Traditional Chinese Medicine

Yuncheng, Shandong, China

Location

PKUCare Luzhong Hospital

Zibo, Shandong, China

Location

Zibo Central Hospital

Zibo, Shandong, China

Location

Related Publications (9)

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  PMID: 28456631 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

• Ding SZ, Du YQ, Lu H, Wang WH, Cheng H, Chen SY, Chen MH, Chen WC, Chen Y, Fang JY, Gao HJ, Guo MZ, Han Y, Hou XH, Hu FL, Jiang B, Jiang HX, Lan CH, Li JN, Li Y, Li YQ, Liu J, Li YM, Lyu B, Lu YY, Miao YL, Nie YZ, Qian JM, Sheng JQ, Tang CW, Wang F, Wang HH, Wang JB, Wang JT, Wang JP, Wang XH, Wu KC, Xia XZ, Xie WF, Xie Y, Xu JM, Yang CQ, Yang GB, Yuan Y, Zeng ZR, Zhang BY, Zhang GY, Zhang GX, Zhang JZ, Zhang ZY, Zheng PY, Zhu Y, Zuo XL, Zhou LY, Lyu NH, Yang YS, Li ZS; National Clinical Research Center for Digestive Diseases (Shanghai), Gastrointestinal Early Cancer Prevention & Treatment Alliance of China (GECA), Helicobacter pylori Study Group of Chinese Society of Gastroenterology, and Chinese Alliance for Helicobacter pylori Study. Chinese Consensus Report on Family-Based Helicobacter pylori Infection Control and Management (2021 Edition). Gut. 2022 Feb;71(2):238-253. doi: 10.1136/gutjnl-2021-325630. Epub 2021 Nov 26.

  PMID: 34836916 BACKGROUND

• Lv ZF, Wang FC, Zheng HL, Wang B, Xie Y, Zhou XJ, Lv NH. Meta-analysis: is combination of tetracycline and amoxicillin suitable for Helicobacter pylori infection? World J Gastroenterol. 2015 Feb 28;21(8):2522-33. doi: 10.3748/wjg.v21.i8.2522.

  PMID: 25741163 BACKGROUND

• Marko D, Calvet X, Ducons J, Guardiola J, Tito L, Bory F; GRESCA (Group for Eradication Studies from Catalonia and Aragon). Comparison of two management strategies for Helicobacter pylori treatment: clinical study and cost-effectiveness analysis. Helicobacter. 2005 Feb;10(1):22-32. doi: 10.1111/j.1523-5378.2005.00288.x.

  PMID: 15691312 BACKGROUND

• Calvet X, Montserrat A, Guell M, Vergara M, Gene E. Ranitidine-bismuth citrate, tetracycline and metronidazole followed by triple therapy as alternative strategy for Helicobacter pylori treatment: a pilot study. Eur J Gastroenterol Hepatol. 2004 Oct;16(10):987-90. doi: 10.1097/00042737-200410000-00006.

  PMID: 15371921 BACKGROUND

• Xie Y, Zhu Z, Wang J, Zhang L, Zhang Z, Lu H, Zeng Z, Chen S, Liu D, Lv N; the Chinese Study Group on Helicobacter pylori, Chinese Society of Gastroenterology. Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00432-18. doi: 10.1128/AAC.00432-18. Print 2018 Sep.

  PMID: 29914954 BACKGROUND

• Zhang J, Han C, Lu WQ, Wang N, Wu SR, Wang YX, Ma JP, Wang JH, Hao C, Yuan DH, Liu N, Shi YQ. A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment. J Dig Dis. 2020 May;21(5):256-263. doi: 10.1111/1751-2980.12870. Epub 2020 Jun 9.

  PMID: 32348007 BACKGROUND

• Ding YM, Zhang QM, Li RL, Han ZX, Zhao Q, Xu LD, Wang KY, Nan XP, Duan M, Zeng SY, Kong QZ, Wang H, Wu XQ, Zhang N, Li YQ, Zuo XL, Li YY. Tetracycline Three Times Daily Versus Four Times Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Multicenter, Noninferiority, Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13121. doi: 10.1111/hel.13121.

  PMID: 39097924 DERIVED

MeSH Terms

Interventions

Amoxicillin; Esomeprazole

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; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

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: June 18, 2022
• First Posted: June 24, 2022
• Study Start: July 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

CN (6)