Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

Dyspepsia Clinical Trial

Official title:

Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857425
• Other study ID #: KY20192009-F-1
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: September 15, 2019

Study information

• Verified date: February 2019
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 15, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Gastritis
• H Pylori Infection

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi`an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks