Status:
COMPLETED
Assessment of the Adjuvant Role of Dietary Supplementation of Antibiotic-tolerant Probiotics in Standard Therapy for the Eradication of Helicobacter Pylori Infection.
Lead Sponsor:
IBSA Farmaceutici Italia Srl
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized, double-blind, placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics, derived from Lactobacillus acidophilus and Bifidob...
Detailed Description
Randomized, double-blind, placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics, in standard therapy for the eradication of H. pylo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2025
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06499649
Start Date
July 3 2024
End Date
May 5 2025
Last Update
July 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Policlinico S. Orsola - Malpighi - Università di Bologna
Bologna, Italy, Italy, 40138