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Berberine for the intestinal metaplasia after endoscopic therapy for early-stage gastric cancer

Exploratory randomized controlled trial to evaluate intestinal metaplasia improvement of gastric mucosa with berberine in patients after endoscopic therapy for early-stage gastric cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210319
Enrollment
30
Registered
2021-09-16
Start date
2022-06-20
Completion date
Unknown
Last updated
2026-06-29

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 after endoscopic therapy for early-stage gastric cancer intestinal metaplasia

Interventions

After the study registry, intestinal metaplasia score of gastric corpus upper gastrointestinal endoscopy and gastric biopsy (updated Sydney system) is evaluated, and only cases with 2 or more score co
D001599
berberine

Sponsors

Sue Soichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Person who have endoscopic therapy history for early-gastric cancer and whose early-gastric cancer was pathologically curative resected. Gastric cancer histological type is note limited. (2)Person whose background gastric mucosa at the point of endoscopic therapy for early-gastric cancer was diagnosed as histological intestinal metaplasia (3)Person who is 20 years or older (4)Both sexes (5)Person who can declare agreement for registering by understanding the study and signing the document after hearing the explanation

Exclusion criteria

Exclusion criteria: (1)Person who take berberine as medication within a year (2)Person who take berberine as supplement within a year (3)Hemorrhagic colitis patient (4)Bacterial enteritis patient (5)Patient who successfully eradicated Helicobacter pylori within a year (6)Patient regularly taking COX2 inhibitor (7)Patient regularly taking NSAIDs (8)Patient regularly taking anticoagulants (warfarin, edoxaban, dabigatran, rivaroxaban, apixaban) (9)Patient regularly taking antiplatelet drug (aspirin, ticlopidine, clopidogrel, cilostazol, Ethyl icosapentate, clopidogrel) (10)Pregnant (11)Patients who are disqualified for the study by physicians

Design outcomes

Primary

MeasureTime frame
Improvement rate of histological intestinal metaplasia in gastric corpus 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

MeasureTime frame
1) Change between before and after intervention: histological intestinal metaplasia score of gastric corpus (updated Sydney system) 2) Change between before and after intervention: histological intestinal metaplasia score of gastric antrum (updated Sydney system) 3) Change between before and after intervention: histological intestinal metaplasia score of gastric angle (updated Sydney system) 4) Change between before and after intervention: histological chronic inflammation score of gastric corpus (updated Sydney system) 5) Change between before and after intervention: histological chronic inflammation score of gastric antrum (updated Sydney system) 6) Change between before and after intervention: histological chronic inflammation score of gastric angle (updated Sydney system) 7) Change between before and after intervention: histological acute inflammation score of gastric corpus (updated Sydney system) 8) Change between before and after intervention: histological acute inflammation score of gastric antrum (updated Sydney system) 9) Change between before and after intervention: histological acute inflammation score of gastric angle (updated Sydney system) 10) Change between before and after intervention: histological atrophy score of gastric corpus (updated Sydney system) 11) Change between before and after intervention: histological atrophy score of gastric antrum (updated Sydney system) 12) Change between before and after intervention: histological atrophy score of gastric angle (updated Sydney system) 13) Change between before and after intervention: Total endoscopic gastric cancer risk score (Kyoto classification of gastritis): total of atrophy, intestinal metaplasia, diffuse redness, enlarged fold, and nodular. 14) Change between before and after intervention: endoscopic atrophy score (Kyoto classification of gastritis) 15) Change between before and after intervention: endoscopic intestinal metaplasia score (Kyoto classification of gastritis) 16) Change betw

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: Jul 3, 2026