Clinical trial NCT02633930: Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy
Official title: Helicobacter Pylori Eradication With Berberine Hydrochloride, Lansoprazole, Amoxicillin and Bismuth Versus Clarithromycin Bismuth, Lansoprazole and Amoxicillin: A Randomized, Open-label, Non-inferiority, Phase Ⅳ Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastritis
Peptic Ulcer
Dyspepsia
Keywords: helicobacter pylori
berberine-containing quadruple therapy
clarithromycin-containing quadruple therapy
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 berberine-containing quadruple therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to clarithromycin-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. 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 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\~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. Underwent upper gastrointestinal Surgery.
7. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
8. Evidence of bleeding or iron efficiency anemia.
9. A history of malignancy.
10. Drug or alcohol abuse history in the past 1 year.
11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
12. Enrolled in other clinical trials in the past 3 months.

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
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Disease
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: Yongquan Shi, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: