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

NCT03997279 | Unknown Phase 4

• 1 other identifier: AB-2019-4
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori; Saccharomyces boulardi; Eradication therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Side effects of eradication therapy

  baseline to 8 weeks after the introduction of the therapy

• Compliance of eradication therapy

  baseline to 8 weeks after the introduction of the therapy

Study Arms (2)

S.boulardi

EXPERIMENTAL

Quadruple eradication therapy with S. boulardi

Drug: Saccharomyces boulardii

Placebo

PLACEBO COMPARATOR

Quadruple eradication therapy without S. boulardi

Drug: Placebo

Interventions

Saccharomyces boulardii DRUG

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

Also known as: Rabeprazole, Amoxicillin, Clarithromycin, Metronidazole

S.boulardi

Placebo DRUG

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

Also known as: Rabeprazole, Amoxicillin, Clarithromycin, Metronidazole

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Dyspepsia
• Patients not treated for H. Pylori
• Age of 18-50 years
• Positive urea breath test

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Centre of Serbia: lead

MeSH Terms

Interventions

Rabeprazole; Amoxicillin; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Central Study Contacts

Miodrag Krstic, MD, PhD

CONTACT

+381113615575; krstic.miodrag61@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 25, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 25, 2019

Record last verified: 2019-06