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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03997279
• Other study ID #: AB-2019-4
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2019
• Est. completion date: June 2020

Study information

• Verified date: June 2019
• Source: Clinical Centre of Serbia
• Contact: Miodrag Krstic, MD, PhD
• Phone: +381113615575
• Email: krstic.miodrag61[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Saccharomyces boulardii
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
• Placebo
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Centre of Serbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result of urea breath test (Eradication of H.pylori)	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	Side effects of eradication therapy	Number and severity of adverse events of standard eradication therapy	baseline to 8 weeks after the introduction of the therapy
Secondary	Compliance of eradication therapy	Patient successfully completed prescribed therapy	baseline to 8 weeks after the introduction of the therapy