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

Primary Purpose

Gastritis, Peptic Ulcer, Dyspepsia

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Clostridium butyricum capsule

esomeprazole

amoxicillin

clarithromycin

Bacillus clotting

Bismuth

About this trial

This is an interventional treatment trial for Gastritis focused on measuring Helicobacter pylori, Probiotics-combining triple therapy, Bismuth-combining quadruple therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 18~75,both gender.
Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
Patients are willing to receive eradication treatment.
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:

Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
contraindications or allergies to research drugs.
Substantial organ impairment(eg liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease.
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).
Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma.
Pregnant or lactating women.
Underwent upper gastrointestinal Surgery.
highly atypical hyperplasia, have symptom of dysphagia.
Evidence of bleeding or iron eficiency anemia.
A history of malignancy.
Drug or alcohol abuse history in the past 1 year.
Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
a person with a mental disorder
Enrolled in other clinical trials in the past 3 months.
Refusal to sign informed consent.

Sites / Locations

Xijing Hospital of Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Clostridium butyricum group

Bacillus clotting group

bismuth quadruple therapy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

helicobacter pylori eradication

The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication.

Secondary Outcome Measures

symptoms effective rates

Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%. Total score = frequency + severity. Frequency score is calculated by all the frequency of heartburn,reflux,abdominal pain,and flatulence. Severity is accumulated by the degree of symptoms described above,which is divided to 4 degree as 0 presenting none,and 3 presenting most severe.

adverse events

Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain.

Full Information

NCT ID

NCT05237115

First Posted

July 12, 2021

Last Updated

February 8, 2022

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT05237115

Brief Title

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

Official Title

Helicobacter Pylori Eradication Clostridium Butyricum Capsule and Bacillus Coagulans Tablets With Hydrochloride,Esomeprazole,Amoxicillin and Bismuth-containing Quadruple Therapy: a Randomized,Single-center，Open-label,Phase Ⅳ Trail

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 5, 2020 (Actual)

Primary Completion Date

December 5, 2020 (Actual)

Study Completion Date

December 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastritis, Peptic Ulcer, Dyspepsia

Keywords

Helicobacter pylori, Probiotics-combining triple therapy, Bismuth-combining quadruple therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clostridium butyricum group

Arm Type

Experimental

Arm Description

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.

Arm Title

Bacillus clotting group

Arm Type

Experimental

Arm Description

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.

Arm Title

bismuth quadruple therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Name(s)

Clostridium butyricum capsule

Intervention Description

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

Intervention Name(s)

esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

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

Intervention Name(s)

amoxicillin

Other Intervention Name(s)

Amoxy ( Uni-Amocin )

Intervention Description

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

Intervention Name(s)

clarithromycin

Intervention Description

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

Intervention Name(s)

Bacillus clotting

Intervention Description

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

Intervention Name(s)

Bismuth

Other Intervention Name(s)

Bitnal

Intervention Description

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.

Primary Outcome Measure Information:

Title

helicobacter pylori eradication

Description

The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication.

Time Frame

28 days after treatment

Secondary Outcome Measure Information:

Title

symptoms effective rates

Description

Time Frame

14 days of treatment, and 28 days after treatment

Title

adverse events

Description

Time Frame

14 days of treatment, and 28 days after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18~75,both gender. Patients with upper gastrointestinal symptoms and with documented H.pylori infection. Patients are willing to receive eradication treatment. 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: Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori. contraindications or allergies to research drugs. Substantial organ impairment(eg liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease. 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). Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma. Pregnant or lactating women. Underwent upper gastrointestinal Surgery. highly atypical hyperplasia, have symptom of dysphagia. Evidence of bleeding or iron eficiency anemia. A history of malignancy. Drug or alcohol abuse history in the past 1 year. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). a person with a mental disorder Enrolled in other clinical trials in the past 3 months. Refusal to sign informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongquan Shi, Ph. D

Organizational Affiliation

Xijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital of Digestive Diseases

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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