intestinal metaplasia intestinal metaplasia
Conditions
Interventions
After registration, a biopsy will be performed by upper gastrointestinal endoscopy (within 30 days of registration), and if the histological intestinal metaplasia score in the gastric fundus is 2 or h
Gastric microbiota eradication
Sponsors
Sue Soichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who are considered to have endoscopically suspected intestinal metaplasia based on an endoscopic examination within the past 3 months to 1 year 2. Individuals who are clinically evaluated as having successfully eradicated H. pylori after eradication therapy or as not currently infected with H. pylori 3. Individuals who can undergo upper gastrointestinal endoscopy and biopsy before the trial treatment, and upper gastrointestinal endoscopy and biopsy 1 year +- 3 months after the trial treatment
Exclusion criteria
Exclusion criteria: (1) Individuals who are taking anticoagulants (warfarin potassium, edoxaban, dabigatran, rivaroxaban, apixaban) (2) Individuals who are taking antiplatelet drugs (aspirin, ticlopidine, clopidogrel, cilostazol, ethyl icosapentate, prasugrel (3) Individuals who are pregnant or may be pregnant (4) Individuals who are in the lactation period (5) Individuals with a history of allergy to vonoprazan, metronidazole, or sitafloxacin (6) Individuals who have received Helicobacter pylori eradication therapy with vonoprazan, metronidazole, and sitafloxacin in the past (7) Individuals who are receiving atazanavir sulfate or lopinavir hydrochloride (8) Individuals with organic disorders of the brain or spinal cord.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of histological intestinal metaplasia in gastric antrum Definition: In this study, patients with two or more score of intestinal metaplasia score (updated sydney system) in gastric corpus are intervened. After the intervention with berberine group or control group, patients with one or less the score defined as improved. Primary outcome is improvement rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in the composition of gastric microbiota before and after intervention, as well as changes in the occupancy ratio of the constituent bacteria. 2.Change in the histological intestinal metaplasia (body) score before and after intervention. 3.Change in the histological intestinal metaplasia (gastric angle) score before and after intervention. 4.Change in the histological chronic inflammation (antrum) score before and after intervention. 5.Change in the histological chronic inflammation (body) score before and after intervention. 6.Change in the histological chronic inflammation (gastric angle) score before and after intervention. 7.Change in the histological acute inflammation (antrum) score before and after intervention. 8.Change in the histological acute inflammation (body) score before and after intervention. 9.Change in the histological acute inflammation (gastric angle) score before and after intervention. 10.Change in the histological atrophy (antrum) score before and after intervention. 11.Change in the histological atrophy (body) score before and after intervention. 12.Change in the histological atrophy (gastric angle) score before and after intervention. 13.Change in the "Endoscopic findings score for gastric cancer risk" before and after intervention. 14.Change in the endoscopic intestinal metaplasia score before and after intervention. 15.Change in the endoscopic atrophy score before and after intervention. 16.Change in the endoscopic diffuse reddening score before and after intervention. 17.Change in the endoscopic fold thickening score before and after intervention. 18.Change in the endoscopic nodular gastritis score before and after intervention. 19.Change in the expression of the intestinal metaplasia-related marker CDX2 before and after intervention. 20.Change in the expression of the intestinal metaplasia-related marker ISX before and after intervention. | — |
Contacts
Public ContactSoichiro Sue
Yokohama City University Hospital
Outcome results
None listed