Impact of oral Helicobacter pylori on gastric infection treatment effectiveness
Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy
This study is testing how having an oral Helicobacter pylori infection affects the success of treatment for stomach infections caused by the same bacteria in adults aged 18 to 70.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05790525 on ClinicalTrials.gov |
What this trial studies
This study evaluates how an oral Helicobacter pylori infection affects the success of treatment for gastric Helicobacter pylori infections. Patients aged 18 to 70 diagnosed with gastric Helicobacter pylori will receive standard bismuth quadruple therapy and undergo various tests to confirm the eradication of both gastric and oral Helicobacter pylori. The study aims to provide insights into the relationship between oral and gastric infections and their treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of gastric Helicobacter pylori infection who have not received dental care in the past year.
Not a fit: Patients with serious organ damage, severe oral diseases, or those currently on antiulcer medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for Helicobacter pylori infections, leading to higher eradication rates.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have shown varying success in treating Helicobacter pylori infections with different methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18\~70 ,both gender. 2. Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection. 3. Have not received dental care or systemic periodontal basic treatment in the past 1 year. Exclusion Criteria: 1. Those who have contraindications to the drugs used in this institute or are allergic to the drugs used. 2. There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases. 3. Ongoing use of antiulcer medications (including PPIs taken within 2 weeks before Helicobacter pylori infection testing), antibiotics, or bismuth complexes (more than 3 times/week before screening). 4. Those with severe oral diseases and malignant tumors of the mouth. 5. Women planning pregnancy, pregnancy and breastfeeding. 6. Previously had upper gastrointestinal surgery. 7. Those who do not take their medication on time. 8. Refusal to sign informed consent.
Where this trial is running
Xi'an, Shaanxi
- Xijing Hosipital of Digestive Disease — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Jiaojiao Cao
- Email: 2119811879@qq.com
- Phone: : +86-15029258646
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.