NCT05742568CompletedPhase 4
Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 124 (actual)
- First submitted
- 3 Feb 2023
- Start date
- 1 Dec 2022
- Primary completion date
- 2 Dec 2023
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05742568
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 124
- From 1 Dec 2022 to the primary completion date, 2 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have had a definite diagnosis of Hp infection and have been treated with antibiotic eradication therapy.
- Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (taken at least 2 weeks prior to the screening for Hp infection)
- Having undergone upper gastrointestinal surgery.
- Received other clinical trials within the past 3 months
Other illness
- Patients with contraindications to or allergies to the study drug.
- Patients with severe organ damage and complications (e.g., cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease
- Evidence of bleeding or iron deficiency anemia.
- History of malignancy.
- History of drug or alcohol abuse within the last 1 year.
- Those with psychiatric disorders.
Lab values
- Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for the use of aspirin ≤100 mg/d)
Other
- Pregnant and lactating women.
- Have symptoms of dysphagia.
- Refusal to sign the informed consent form.
Who the study is looking for
- Age 18 to 70 years, regardless of gender.
- Patients with definite Hp infection (positive for either 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) and who have not received H. pylori eradication therapy.
- Voluntary Hp eradication therapy.
- Women of childbearing potential are required to use a medically advisable form of contraception during the trial and for 30 days after the trial ends.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing Hosipital of Digestive Disease Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.