Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter Pylori, Saccharomyces boulardi, Eradication therapy
Brief summary
This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.
Detailed description
Standard triple therapy for H. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.Therefore, the latest Maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. The addition of probiotics with eradication therapy has never become a standard treatment. However, the Maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy. The study was designed as a prospective, double-blind, randomized, case-control intervention study.
Interventions
Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Saccharomyces boulardi 500 mg 1x1, for 3 week
DRUGPlacebo
Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Placebo 1x1, for 3 week
Sponsors
Clinical Centre of Serbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Dyspepsia * Patients not treated for H. Pylori * Age of 18-50 years * Positive urea breath test
Exclusion criteria
* Alarm symptoms (anemia, persistent vomiting, hematemesis, dysphagia, significant weight loss, palpable mass in abdomen) * Gastric cancer * Immunosuppressive therapy * Use of acetylsalicylic acid * Severe renal failure * Severe liver failure * Immunodeficiency * Proven malignant disease * Penicillin allergy * Allergy to any component of dietary supplement (Saccharomyces boulardii and Vitamin D) * Chronic alcoholism * Pregnancy * Lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Result of urea breath test (Eradication of H.pylori) | baseline to 8 weeks after the introduction of the therapy | Test remains positive (Eradication of H.pylori unsuccessful) or test becomes negative (eradication of H.pylori successful) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects of eradication therapy | baseline to 8 weeks after the introduction of the therapy | Number and severity of adverse events of standard eradication therapy |
| Compliance of eradication therapy | baseline to 8 weeks after the introduction of the therapy | Patient successfully completed prescribed therapy |
Contacts
Primary ContactMiodrag Krstic, MD, PhD
Outcome results
None listed