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

Phase 2

Recruiting

• Conditions: Patients with gastric intestinal metaplasia after endoscopic therapy for early-stage gastric cancer; intestinal metaplasia

• Registration Number: JPRN-jRCTs031210319
• Lead Sponsor: Sue Soichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement rate of histological intestinal metaplasia in gastric corpus<br>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.