- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997279
Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii
Double-blind, Placebo-controlled, Randomized Study for Assesment of the Efficiency and Safety Quadruple Therapy for Helicobacter Pylori Infection With or Without the Addition of Saccharomyces Boulardi Probiotic
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Miodrag Krstic, MD, PhD
- Phone Number: +381113615575
- Email: krstic.miodrag61@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: S.boulardi
Quadruple eradication therapy with S. boulardi
|
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
Other Names:
|
Placebo Comparator: Placebo
Quadruple eradication therapy without S. boulardi
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Result of urea breath test (Eradication of H.pylori)
Time Frame: 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)
|
baseline to 8 weeks after the introduction of the therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effects of eradication therapy
Time Frame: baseline to 8 weeks after the introduction of the therapy
|
Number and severity of adverse events of standard eradication therapy
|
baseline to 8 weeks after the introduction of the therapy
|
Compliance of eradication therapy
Time Frame: baseline to 8 weeks after the introduction of the therapy
|
Patient successfully completed prescribed therapy
|
baseline to 8 weeks after the introduction of the therapy
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Infections
- Helicobacter Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Metronidazole
- Rabeprazole
- Amoxicillin
- Clarithromycin
Other Study ID Numbers
- AB-2019-4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Helicobacter Pylori Infection
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingHelicobacter Pylori Infection | Helicobacter Pylori EradicationBangladesh
-
Shandong UniversityRecruitingHelicobacter Pylori Infection | Patient Education | Helicobacter Pylori EradicationChina
-
Shandong UniversityCompletedHelicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationChina
-
Shanghai Jiao Tong University School of MedicineCompletedCure Rate of Helicobacter Pylori InfectionChina
-
Seoul National University Bundang HospitalRecruitingHelicobacter Pylori Infection | Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation | Helicobacter Pylori Associated Gastrointestinal Disease | Helicobacter Pylori Infection, Susceptibility toKorea, Republic of
-
The First Affiliated Hospital of Nanchang UniversityUnknownBacterial Infection Due to Helicobacter Pylori (H. Pylori) | Eradication Therapy of Helicobacter Pylori | Detection of Helicobacter PyloriChina
-
Tanta UniversityNot yet recruitingPersistent Helicobacter Pylori InfectionEgypt
-
National University Hospital, SingaporeUnknownHELICOBACTER PYLORI INFECTIONSSingapore
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedHelicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)Helicobacter Pylori Infection | Helicobacter Pylori gyrA Levofloxacin Resistance Mutation | Fecal Drug Resistance Gene Detection | Helicobacter Pylori Infection, Susceptibility toChina
-
Kaohsiung Veterans General Hospital.Kaohsiung Medical University Chung-Ho Memorial HospitalCompletedHelicobacter Pylori InfectionTaiwan
Clinical Trials on Saccharomyces boulardii
-
BiocodexCompletedHIV Infections | DiarrheaUnited States
-
Universidade Federal FluminenseCompleted
-
Federal University of Minas GeraisCompletedColorectal Cancer
-
BiocodexCompletedAcute GastroenteritisArgentina
-
Zekai Tahir Burak Women's Health Research and Education...UnknownNecrotizing Enterocolitis | Very Low Birth Weight InfantsTurkey
-
Fakultas Kedokteran Universitas IndonesiaNot yet recruitingIrritable Bowel Syndrome
-
Aga Khan UniversityUnknownIrritable Bowel SyndromePakistan
-
Federal University of Minas GeraisCompletedLiver CirrhosisBrazil
-
Sinaloa Pediatric HospitalWithdrawn
-
Tatyasaheb Kore Dental CollegeCompletedChronic PeriodontitisIndia