Status:
COMPLETED
Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Gastritis
Peptic Ulcer
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study aims at evaluating efficacy and safety of probiotics combined with triple therapy (Clostridium butyricum capsule and Bacillus coagulans tablets, esomeprazole, clarithromycin and amoxicillin...
Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signatur...
Eligibility Criteria
Inclusion
- Age between 18\~75,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 or allergies to research drugs.
- Substantial organ impairment(eg liver cirrhosis, uremia, etc.), 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).
- Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma.
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
- highly atypical hyperplasia, have symptom of dysphagia.
- Evidence of bleeding or iron eficiency 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).
- a person with a mental disorder
- Enrolled in other clinical trials in the past 3 months.
- Refusal to sign informed consent.
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2020
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05237115
Start Date
May 5 2020
End Date
December 5 2020
Last Update
February 11 2022
Active Locations (1)
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1
Xijing Hospital of Digestive Diseases
Xi’an, Shanxi, China, 710032