Comparing Bismuth Quadruple Therapy to Standard Triple Therapy for H. pylori in Children
Bismuth Quadruple Therapy Versus Standard Triple Therapy for the First-line Treatment of Helicobacter Pylori Infection in Children: Efficacy and Safety
This study is testing if a new four-drug treatment for H. pylori can work better than the usual three-drug treatment in children aged 5 to 18.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT06143124 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of Bismuth quadruple therapy compared to the standard triple therapy for treating Helicobacter pylori infections in children aged 5 to 18 years. Participants will be randomized into two groups receiving either a 7-day or a 14-day eradication therapy. The study will assess the effectiveness of the Bismuth subcitrate regimen in eradicating the infection, particularly in light of rising antibiotic resistance. The trial seeks to improve treatment outcomes and compliance in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 18 years with confirmed H. pylori infection who have not previously undergone treatment for this infection.
Not a fit: Patients with significant gastrointestinal diseases or those who have recently received antibiotics or proton pump inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for children suffering from H. pylori infections.
How similar studies have performed: Other studies have shown varying success with different antibiotic regimens for H. pylori, but the specific use of Bismuth quadruple therapy in children is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Male or female patients * Age between 5 - 18 years with a * Minimum body weight of 15 kg * Endoscopy performed with biopsies taken for culture, histology * No previous therapy for H. pylori infection * Written informed consent * H. pylori infection confirmed by positive culture and with susceptibility testing for clarithromycin and metronidazole to allow tailored therapy Exclusion Criteria: * Significant acute or chronic gastrointestinal disease (IBD, coeliac disease, GERD etc.) or other organic disease interfering with symptom assessment * Patients with ulcers and need to be treated with PPI according to the physician judgment. * Known allergies to used antibiotics, proton pump inhibitors or probiotics * Having received treatment with antibiotics or bismuth compounds during the previous 30 days before endoscopy. * Having received proton pump inhibitors during the previous two weeks. * Severe acquired or primary immunodeficiency disorder * Language barriers which do not allow to give informed consent and/or to adequately complete the study diary * Being infected with a strain resistant to clarithromycin and metronidazole (double resistant)
Where this trial is running
Ljubljana
- Matjaž Homan — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Matjaž Homan, MD PhD
- Email: matjaz.homan@guest.arnes.si
- Phone: 0038640885848
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.