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

NCT ID: NCT05997433

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-02
• Study Completion Date: 2024-08-30

Brief 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.

Detailed 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

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

7 days

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Group Type: EXPERIMENTAL

7days bismuth quadruple

Intervention Type: PROCEDURE

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid\*7days

14 days

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Group Type: ACTIVE_COMPARATOR

14 days bismuth quadruple

Intervention Type: PROCEDURE

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid\*14days

Interventions

7days bismuth quadruple

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid\*7days

Intervention Type: PROCEDURE

14 days bismuth quadruple

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid\*14days

Intervention Type: PROCEDURE

Other Intervention Names

Amoxicillin; Tetracycline; Bismuth; Tegoprazan; Amoxicillin; Tetracycline; Bismuth; Tegoprazan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zibo Maternal and Child Health Hospital

UNKNOWN

Sponsor Role: collaborator

Zaozhuang Municipal Hospital

OTHER

Sponsor Role: collaborator

Binzhou Maternal and Child Health Hospital

UNKNOWN

Sponsor Role: collaborator

Jinxiang County People's Hospital

UNKNOWN

Sponsor Role: collaborator

Linyi Yizhou Hospital

UNKNOWN

Sponsor Role: collaborator

Yantai Penglai Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role: collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanqing Li, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanqing Li, Ph.D

Role: CONTACT

liyanqing@sdu.edu.cn

+8653188369277

Facility Contacts

Yanqing Li, PhD. MD.

Role: primary

liyanqing@sdu.edu.cn

18678827666

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Other Identifiers

SHARE2302

Identifier Type: -

Identifier Source: org_study_id