Patients with gastric intestinal metaplasia intestinal metaplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Those who are suspected to have endoscopic intestinal metaplasia based on an endoscopic examination within the past year and three months. (2)Those who have been evaluated as having been successfully eradicated from H. pylori eradication therapy or who have been clinically evaluated as having no current H. pylori infection. (3) Those who are able to undergo upper gastrointestinal endoscopy and biopsy before study treatment and upper gastrointestinal endoscopy and biopsy 1 year + or - 3 months after study treatment. (4)Those who have received a full explanation of this study and have fully understood it, and have given their own voluntary written consent to participate.
Exclusion criteria
Exclusion criteria: (1) Patients who have taken oral berberine or berberine-Gennoshoko extract combination tablets within one year of study enrollment. (2) Patients who have taken berberine as a supplement within one year of study enrollment. (3) Patients with hemorrhagic colitis (4) Patients who have undergone Helicobacter pylori eradication treatment within one year of study enrollment and have been successfully eradicated (5) Patients taking COX2 inhibitors continuously (6) Patients taking NSAIDs continuously (7) Patients taking aspirin continuously (8) Pregnant patients (9) Patients who are deemed inappropriate to be subjects by the principal investigator (subinvestigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of histological intestinal metaplasia Definition: The proportion of sites with an Updated Sydney System intestinal metaplasia score of 2 or more before intervention that decreased to 1 or less after intervention. In this study, intervention was performed when the Updated Sydney System intestinal metaplasia score after enrollment was 2 or more, and the proportion of sites that improved to 1 or less was evaluated by group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in histological intestinal metaplasia (gastric body) score before and after intervention Definition: Difference in intestinal metaplasia score of the Updated Sydney system in the body before and after intervention 2) Change in histological intestinal metaplasia (antrum) score before and after intervention Definition: Difference in intestinal metaplasia score of the Updated Sydney system in the antrum before and after intervention 3) Change in histological intestinal metaplasia (gastric angle) score before and after intervention Definition: Difference in intestinal metaplasia score of the Updated Sydney system in the gastric angle before and after intervention 4) Change in histological chronic inflammation (body) score before and after intervention Definition: Difference in chronic inflammation score of the Updated Sydney system in the body (3 levels, 0-3 points) before and after intervention 5) Change in histological chronic inflammation (antrum) score before and after intervention Definition: Difference in chronic inflammation score of the Updated Sydney system in the antrum (3 levels, 0-3 points) before and after intervention 6) Change in histological chronic inflammation (gastric angle) score before and after intervention Definition: Difference in chronic inflammation score of the Updated Sydney system in the antrum (3 levels, 0-3 points) before and after intervention system chronic inflammation score (3 levels, 0-3 points) before and after intervention 7) Change in histological acute inflammation (body) score before and after intervention Definition: Difference in the acute inflammation score (3 levels, 0-3 points) of the Updated Sydney system of the body before and after intervention 8) Change in histological acute inflammation (antrum) score before and after intervention Definition: Difference in the acute inflammation score (3 levels, 0-3 points) of the Updated Sydney system of the antrum before and after intervention 9) Change in histological acute | — |
Contacts
Yokohama City University Hospital