Improving Helicobacter Pylori eradication with fucoidan
Study on the Effect of Fucoidan Combined With the Eradication Program Containing Vonoprazan on H.Pylori Eradication Rate and Gastrointestinal Flora.
This study is testing if adding fucoidan to standard treatments can help people with Helicobacter pylori infections get rid of the bacteria more effectively.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05461508 on ClinicalTrials.gov |
What this trial studies
This study investigates whether adding fucoidan to a treatment regimen of amoxicillin and vonoprazan can enhance the eradication rate of Helicobacter pylori infections. A total of 60 patients diagnosed with H. pylori will be randomly assigned to receive either the combination of all three medications or just the two standard treatments for 14 days. The study will monitor patients for adverse reactions and compliance, as well as assess changes in gastrointestinal flora through fecal samples collected at various points. The effectiveness of the treatment will be evaluated using a breath test after a four-week drug withdrawal period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who are diagnosed as H. pylori positive and have not previously received eradication treatment.
Not a fit: Patients with a history of chronic gastritis, peptic ulcers, or recent H. pylori treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment options for patients suffering from H. pylori infections.
How similar studies have performed: While the combination of amoxicillin and vonoprazan is established, the addition of fucoidan is a novel approach that has not been widely tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-65 years old; 2. Patients diagnosed as HP positive; 3. Patients who have not received HP eradication treatment in the past, or who have failed in the early eradication but have not received eradication treatment within half a year; 4. Voluntarily participate in this trial and sign the informed consent form. Exclusion Criteria: 1. Allergic to the study drug (penicillin allergy, etc.); 2. Patients with chronic gastritis and peptic ulcer; 3. Patients who have received HP eradication treatment within half a year; 4. Antibiotics and bismuth agents were used 4 weeks before the start of the study treatment, and histamine H2 receptor antagonists or PPIs were used 2 weeks before the start of the study treatment; 5. Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants; 6. History of esophageal or gastric surgery; 7. Pregnant and lactating women; 8. Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
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.