Status:
COMPLETED
Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Gastritis
H Pylori Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 T...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03857425
Start Date
March 1 2019
End Date
September 15 2019
Last Update
September 25 2019
Active Locations (1)
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1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032