Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori : A Multicenter Randomized Non-Inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997433
• Other study ID #: SHARE2302
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• 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

Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of gastric cancer.The researchers collect H.pylori-positive patients who need native therapy. The subjects were randomized to receive7 days and 14 days 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:

Related studies have shown that 7-day bismuth quadruple therapy is not inferior to 14-day bismuth quadruple therapy in the eradication of clarithromycin-resistant H. pylori.The results of the current study conducted by our team on the eradication of H. pylori in 10-day versus 14-day courses of bismuth quadruple therapy showed that the 10-days (92.09%) was not inferior to the 14-days(92.38%), but the incidence of adverse effects was significantly lower in the 10-day courses than in the 14-days(30.62%). If it can be demonstrated that the eradication rate of the 7-day course of bismuth quadruplex is close to that of the 14-days, then the 7-day course may be chosen. The researchers collect H.pylori-positive patients who need native therapy. 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 7days or 14days 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 therapy, it is randomized into a 7days treatment group and a 14 days treatment group. The two groups of bismuth quadruple regimens are the same, as follows: 7days group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid 14days group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18-70.

2. Without active hepatitis.

3. Helicobacter pylori infection (either positive for rapid urease test, C13/C14 urea breath test).

4. Patients who have not previously received helicobacter pylori eradication therapy.

Exclusion Criteria:

1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 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

Procedure:
• 7days bismuth quadruple
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid*7days
• 14 days bismuth quadruple
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid*14days

Locations

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

Sponsors (8)

Lead Sponsor	Collaborator
Shandong University	Binzhou Maternal and Child Health Hospital, Jinxiang County People's Hospital, Linyi Yizhou Hospital, The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine, Yantai Penglai Traditional Chinese Medicine Hospital, Zaozhuang Municipal Hospital, Zibo Maternal and Child Health Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Cho JH, Jin SY. Current guidelines for Helicobacter pylori treatment in East Asia 2022: Differences among China, Japan, and South Korea. World J Clin Cases. 2022 Jul 6;10(19):6349-6359. doi: 10.12998/wjcc.v10.i19.6349. — 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

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, W — View Citation

Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.11 — View Citation

Moon SG, Lim CH, Kang HJ, Choi A, Kim S, Oh JH. Seven Days of Bismuth-Based Quadruple Therapy Is as Effective for the First-Line Treatment of Clarithromycin-Resistant Confirmed Helicobacter pylori Infection as 14 Days of Bismuth-Based Quadruple Therapy. J — 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 naive Helicobacter pylori infected patients in a high clarithromycin resistance area. J Gastroenterol Hepatol. 2021 Sep;36(9):2383- — View Citation

Zhou XZ, Lyu NH, Zhu HY, Cai QC, Kong XY, Xie P, Zhou LY, Ding SZ, Li ZS, Du YQ; National Clinical Research Center for Digestive Diseases (Shanghai), Gastrointestinal Early Cancer Prevention & Treatment Alliance of China (GECA), Helicobacter pylori Study — 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 90%-100% of the dosage that should be taken.	Immediately after follow-up check