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RCT to evaluate berberine for improving intestinal metaplasia

An exploratory randomized controlled trial evaluating the inhibitory effect of berberine on gastric cancer by improving intestinal metaplasia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250217
Enrollment
30
Registered
2025-07-07
Start date
2025-10-08
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with gastric intestinal metaplasia intestinal metaplasia

Interventions

After study enrollment, an upper gastrointestinal endoscopy and biopsy will be performed. If the gastric mucosa has an intestinal metaplasia score of 2 or higher in any site using the Updated Sydney S

Sponsors

Sue Soichiro
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactSoichiro Sue

Yokohama City University Hospital

ssue@yokohama-cu.ac.jp+81-457872800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026