Clinical trial NCT05237115: Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy
Official title: Helicobacter Pylori Eradication Clostridium Butyricum Capsule and Bacillus Coagulans Tablets With Hydrochloride,Esomeprazole,Amoxicillin and Bismuth-containing Quadruple Therapy: a Randomized,Single-center，Open-label,Phase Ⅳ Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastritis
Peptic Ulcer
Dyspepsia
Keywords: Helicobacter pylori
Probiotics-combining triple therapy
Bismuth-combining quadruple therapy
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that probiotics combined with triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

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 signature. 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 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.

Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Eligibility criteria: Inclusion Criteria:

1. Age between 18\~75,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 or allergies to research drugs.
3. Substantial organ impairment(eg liver cirrhosis, uremia, etc.), 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. Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma.
6. Pregnant or lactating women.
7. Underwent upper gastrointestinal Surgery.
8. highly atypical hyperplasia, have symptom of dysphagia.
9. Evidence of bleeding or iron eficiency 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. a person with a mental disorder
14. Enrolled in other clinical trials in the past 3 months.
15. Refusal to sign informed consent.

Primary outcomes:
measure: helicobacter pylori eradication
timeFrame: 28 days after treatment
Secondary outcomes:
measure: symptoms effective rates
timeFrame: 14 days of treatment, and 28 days after treatment
measure: adverse events
timeFrame: 14 days of treatment, and 28 days after treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: Yongquan Shi, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: