Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii

Clinical Centre of Serbia

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Saccharomyces boulardii; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03997279

AB-2019-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

S.boulardi

Experimental group

Description:

Quadruple eradication therapy with S. boulardi

Treatment:

Drug: Saccharomyces boulardii

Placebo

Placebo Comparator group

Description:

Quadruple eradication therapy without S. boulardi

Treatment:

Drug: Placebo