Using probiotics to improve treatment for Helicobacter pylori infection
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 Helicobacter Pylori Infection.
This study is testing if taking special probiotics along with standard treatment can help people with Helicobacter pylori infection feel better and have fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IBSA Farmaceutici Italia Srl Industry-sponsored |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06499649 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the effectiveness of antibiotic-tolerant probiotics as an adjunct to standard therapy for eradicating Helicobacter pylori infection. The study will involve 270 naive patients who have never undergone eradication therapy, comparing the incidence and severity of adverse events between those receiving probiotics and those receiving a placebo. Participants will take either probiotics or placebo for 10 days before starting their eradication therapy, with outcomes assessed through various tests and questionnaires.
Who should consider this trial
Good fit: Ideal candidates are naive patients diagnosed with H. pylori infection who are prescribed eradication therapy and exhibit upper gastrointestinal symptoms.
Not a fit: Patients with a history of previous eradication attempts or those with known gastric diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the adverse effects associated with standard antibiotic therapy for Helicobacter pylori infection.
How similar studies have performed: Other studies have shown promising results with the use of probiotics in conjunction with antibiotic therapy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- Policlinico S. Orsola - Malpighi - Università di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Berardino Vaira, Prof
- Email: berardino.vaira@unibo.it
- Phone: +39-051-2144140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.