Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy of Different Tetracycline Doses and Frequencies.

Helicobacter Pylori Infection Clinical Trial

Official title:

Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy: A Multicenter Randomized Non-Inferiority Trial of Different Tetracycline Doses and Frequencies.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802888
• Other study ID #: 2023000
• Status: Recruiting
• Phase: Phase 4
• Start date: March 12, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2023
• Source: Shandong University
• Contact: Yanqing Li, Ph.D
• Phone: +8653188369277
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researchers collect H.pylori-positive patients who need rescue therapy 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 and patient compliance of each group.

Description:

The researchers collect H.pylori-positive patients who need rescue therapy 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 dose and frequency of tetracycline 500mg tid or qid of bismuth 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 and patient compliance of each group were calculated.

According to the dose and frequency of tetracycline, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid

Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18-70.

2. Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).

3. Patients who have previous failed H. pylori eradication treatment, and = 2 times.

Exclusion Criteria:

1. 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%.

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

3. Patients with active gastrointestinal bleeding.

4. Patients with a history of upper gastrointestinal surgery.

5. Patients allergic to treatment drugs.

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

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Tetracycline 500mg tid
Amoxicillin 1000mg bid +Tetracycline 500mg tid +Bismuth+Esomeprazole 40mg bid
• Tetracycline 500mg qid
Amoxicillin 1000mg bid +Tetracycline 500mg qid +Bismuth+Esomeprazole 40mg bid

Locations

Country	Name	City	State
China	Department of Gastroenterology,QiLu Hospital,Shandong University	Jinan	Shandong

Sponsors (6)

Lead Sponsor	Collaborator
Shandong University	Peking University Care Luzhong Hospital, People's Hospital of Zhengzhou University, Taierzhuang District People's Hospital, Yuncheng County Hospital of Traditional Chinese Medicine, Zibo Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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 — View Citation

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 — 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. 20 — View Citation

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. — 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 — View Citation

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. Helicoba — View Citation

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 Tetracycli — View Citation

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 r — 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.	through study completion, an average of 1.5 years
Secondary	Rate of adverse reactions	Rate of adverse reactions	through study completion, an average of 1.5 years
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.	through study completion, an average of 1.5 years