Assessment of the Adjuvant Role of Dietary Supplementation of Antibiotic-tolerant Probiotics in Standard Therapy for the Eradication of Helicobacter Pylori Infection.

Launched by IBSA FARMACEUTICI ITALIA SRL · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a specific type of probiotics—tiny living organisms that can help with digestion—can improve the standard treatment for a stomach infection caused by a bacteria called Helicobacter pylori (H. pylori). The probiotics in this study are special because they can survive antibiotics, which are medications used to kill bacteria. The goal is to see if these probiotics can help people get rid of the H. pylori infection more effectively alongside their regular treatment.

To participate in this trial, you must be diagnosed with an H. pylori infection and have been prescribed a treatment to help eliminate it. You should not have had previous treatments for H. pylori and should be experiencing symptoms related to your stomach. The trial is currently recruiting participants aged 65 to 74, and both men and women can join. If you decide to participate, you will receive either the probiotics or a placebo (a harmless substance with no active ingredients) along with your usual treatment, and your progress will be monitored throughout the study. This trial aims to learn more about how these probiotics might support your recovery from H. pylori infection.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of H. pylori infection by breath test and histological and/or cultural examination on biopsy (performed within 10 days prior to T0)
• • Prescription of eradication therapy for HP
• • Naïve patients (who have never had eradication therapy for H. pylori)
• • Patients with symptoms of upper gastrointestinal tract
• • Obtaining informed consent
• Exclusion Criteria:
• • Patients with history of previous eradication attempts
• • Patients with known gastric disease (e.g. atrophic gastritis, gastric cancer)
• • Patients with severe organ dysfunction (cirrhosis of the liver, severe renal or respiratory failure, dialysis)
• • Women who are pregnant or breastfeeding
• • Patients unable to provide informed consent