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Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

Primary Purpose

Gastritis, H Pylori Infection, Dyspepsia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Clostridum Butyricum Capsule
Bacillus Coagulans Tablets
Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis focused on measuring Gastritis, H Pylori Infection

Eligibility Criteria

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

Inclusion Criteria:

  1. Age between 18~70,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 to study drugs.
  3. Substantial organ impairment, 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. Pregnant or lactating women.
  6. Patients were diagnosed with gastroduodenal ulcer and MALT lymphoma.
  7. Underwent upper gastrointestinal Surgery.
  8. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
  9. Evidence of bleeding or iron efficiency 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. Enrolled in other clinical trials in the past 3 months.
  14. Patients who has psychological problem or poor compliance.
  15. Refuse to sign informed consent.

Sites / Locations

  • Xijing Hosipital of Digestive Disease

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Clostridum Butyricum Capsule

Bacillus Coagulans Tablets

Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets

Arm Description

Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks

Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks

Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks

Outcomes

Primary Outcome Measures

helicobacter pylori eradication H.pylori eradication
Rate of H.pylori eradication Assessed by urea breath test,rapid urease test or helicobacter pylori stool antigen test after the end of treatment.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2019
Last Updated
September 24, 2019
Sponsor
Xijing Hospital of Digestive Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT03857425
Brief Title
Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets
Official Title
Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
September 15, 2019 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims at evaluating efficacy Clostridum Butyricum Capsule and Bacillus Coagulans Tablets in H. pylori eradication. It is hypothesized that Clostridum Butyricum Capsule , Bacillus Coagulans Tablets monotherapy or Clostridum Butyricum Capsule plus Bacillus Coagulans may have some positive effect on H. pylori eradication.
Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: during this phase subjects eligibility will be evaluated after informed consent signature. Endoscopy and 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 8weeks. Follow-up: includes one visits. 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, H Pylori Infection, Dyspepsia
Keywords
Gastritis, H Pylori Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clostridum Butyricum Capsule
Arm Type
Experimental
Arm Description
Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks
Arm Title
Bacillus Coagulans Tablets
Arm Type
Experimental
Arm Description
Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
Arm Title
Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets
Arm Type
Experimental
Arm Description
Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Clostridum Butyricum Capsule
Intervention Description
Clostridum Butyricum Capsule 3*420mg,twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Bacillus Coagulans Tablets
Intervention Description
Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets
Intervention Description
Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
Primary Outcome Measure Information:
Title
helicobacter pylori eradication H.pylori eradication
Description
Rate of H.pylori eradication Assessed by urea breath test,rapid urease test or helicobacter pylori stool antigen test after the end of treatment.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18~70,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 to study drugs. Substantial organ impairment, 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). Pregnant or lactating women. Patients were diagnosed with gastroduodenal ulcer and MALT lymphoma. Underwent upper gastrointestinal Surgery. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia. Evidence of bleeding or iron efficiency 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). Enrolled in other clinical trials in the past 3 months. Patients who has psychological problem or poor compliance. Refuse to sign informed consent.
Facility Information:
Facility Name
Xijing Hosipital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33157939
Citation
Zhang J, Guo J, Li D, Chen M, Liu J, Feng C, He Q, Zhao J, Zhang L, Chen J, Shi Y. The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study. Medicine (Baltimore). 2020 Nov 6;99(45):e22976. doi: 10.1097/MD.0000000000022976.
Results Reference
derived

Learn more about this trial

Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

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