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Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03857425
Recruitment Status : Completed
First Posted : February 28, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yongquan Shi, Xijing Hospital of Digestive Diseases

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.

Condition or disease Intervention/treatment Phase
Gastritis H Pylori Infection Dyspepsia Drug: Clostridum Butyricum Capsule Drug: Bacillus Coagulans Tablets Drug: Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : September 15, 2019

Arm Intervention/treatment
Experimental: Clostridum Butyricum Capsule
Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks
Drug: Clostridum Butyricum Capsule
Clostridum Butyricum Capsule 3*420mg,twice daily for 8 weeks

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

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




Primary Outcome Measures :
  1. helicobacter pylori eradication H.pylori eradication [ Time Frame: 8 weeks ]
    Rate of H.pylori eradication Assessed by urea breath test,rapid urease test or helicobacter pylori stool antigen test after the end of treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857425


Locations
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China, Shaanxi
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
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Responsible Party: Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT03857425    
Other Study ID Numbers: KY20192009-F-1
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yongquan Shi, Xijing Hospital of Digestive Diseases:
Gastritis
H Pylori Infection
Additional relevant MeSH terms:
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Gastritis
Dyspepsia
Signs and Symptoms, Digestive
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases