Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy

NCT ID: NCT05237115

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2020-12-05

Brief Summary

This study aims at evaluating efficacy and safety of probiotics combined with triple therapy (Clostridium butyricum capsule and Bacillus coagulans tablets, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that probiotics combined with triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

Detailed Description

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.

Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Conditions

Gastritis; Peptic Ulcer; Dyspepsia

Study Design

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

Study Groups

Clostridium butyricum group

given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Group Type: EXPERIMENTAL

Clostridium butyricum capsule

Intervention Type: DRUG

Clostridium butyricum group: given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

esomeprazole

Intervention Type: DRUG

Esmeprazole 40mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

amoxicillin

Intervention Type: DRUG

Amoxicillin 500 mg 2 capsules BID plus esmeprazole 40mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

clarithromycin

Intervention Type: DRUG

Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 40mg 1tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Bacillus clotting group

given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Group Type: EXPERIMENTAL

esomeprazole

Intervention Type: DRUG

Esmeprazole 40mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

amoxicillin

Intervention Type: DRUG

Amoxicillin 500 mg 2 capsules BID plus esmeprazole 40mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

clarithromycin

Intervention Type: DRUG

Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 40mg 1tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Bacillus clotting

Intervention Type: DRUG

given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

bismuth quadruple therapy

given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Group Type: ACTIVE_COMPARATOR

esomeprazole

Intervention Type: DRUG

Esmeprazole 40mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

amoxicillin

Intervention Type: DRUG

Amoxicillin 500 mg 2 capsules BID plus esmeprazole 40mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

clarithromycin

Intervention Type: DRUG

Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 40mg 1tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Bismuth

Intervention Type: DRUG

given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Interventions

Clostridium butyricum capsule

Clostridium butyricum group: given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Intervention Type: DRUG

esomeprazole

Esmeprazole 40mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Intervention Type: DRUG

amoxicillin

Amoxicillin 500 mg 2 capsules BID plus esmeprazole 40mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Intervention Type: DRUG

clarithromycin

Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 40mg 1tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Intervention Type: DRUG

Bacillus clotting

given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Intervention Type: DRUG

Bismuth

given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Intervention Type: DRUG

Other Intervention Names

Nexium; Amoxy ( Uni-Amocin ); Bitnal

Eligibility Criteria

Inclusion Criteria

1. Age between 18~75,both gender.

2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.

3. Patients are willing to receive eradication treatment.

4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria

1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.

2. contraindications or allergies to research drugs.

3. Substantial organ impairment(eg liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease.

4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).

5. Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma.

6. Pregnant or lactating women.

7. Underwent upper gastrointestinal Surgery.

8. highly atypical hyperplasia, have symptom of dysphagia.

9. Evidence of bleeding or iron eficiency anemia.

10. A history of malignancy.

11. Drug or alcohol abuse history in the past 1 year.

12. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).

13. a person with a mental disorder

14. Enrolled in other clinical trials in the past 3 months.

15. Refusal to sign informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Yongquan Shi

Professor/Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongquan Shi, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, China

Countries

China

Other Identifiers

K111111

Identifier Type: -

Identifier Source: org_study_id