Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

Phase 4

Completed

• Conditions: H Pylori Infection; Gastritis; Dyspepsia
• Interventions: Drug: Clostridum Butyricum Capsule; Drug: Bacillus Coagulans Tablets; Drug: Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets

• Registration Number: NCT03857425
• Lead Sponsor: 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.

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).

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Study Start: 2019-03-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-09-15
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clostridum Butyricum Capsule	Clostridum Butyricum Capsule	Clostridum Butyricum Capsule 3\*420mg, twice daily for 8 weeks
Bacillus Coagulans Tablets	Bacillus Coagulans Tablets	Bacillus Coagulans Tablets 3\*350mg, three times daily for 8 weeks
Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets	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

Name	Time	Method
helicobacter pylori eradication H.pylori eradication	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.

Trial Locations

Locations (1)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China