Influence of Rebamipide on gastritis in patients with gastritis who underwent endoscopic retrograde cholangiopancreatography due to choledocholithiasis: A pilot study

Not Applicable

Conditions: Diseases of the digestive system

Registration Number: KCT0008550

Lead Sponsor: Jeonbuk National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Patients aged 19 and older who have given voluntary consent to the study and signed the Informed Consent Form (ICF)
-Patients underwent ERCP for the first time after being diagnosed with choledocholithiasis through an imaging examination
-Patients confirmed to have erosive gastritis, acute superficial gastritis, etc., through EGD prior to ERCP

Exclusion Criteria

-Patients diagnosed with malignant tumors
-Patients underwent surgeries for the gastrointestinal and biliary system
-Patients accompanied by a peptic ulcer requiring treatments
-Patients who need to maintain biliary stent (plastic or metallic)
-Patients diagnosed with inflammatory bowel disease
-Patients diagnosed with rheumatology disease
-Patients who have taken the following medications within the last 2 weeks whose concomitant administration is prohibited (PPI, H2RA, mucoprotective agent, antibiotics, NSAIDs, probiotics, prebiotics, steroids, and immunosuppressants)
-As a result of the screening test, pregnant women, lactating women, and patients who may become pregnant and do not use appropriate contraceptive methods (e.g., hormone implantation, intrauterine device, oral contraceptives, etc.).

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-In order to compare the rebamipide group and the non-rebamipide group, continuous variables will be compared using the independent samples t-test, and categorical data will be compared using the cross-tabulation analysis (Chi-Square Test or Fisher’s exact test). For statistical analysis, SPSS ver. 25.0 (SPSS Inc, Chicago, IL, USA) was used; if P-value is < 0.05, it will be considered statistically significant. -The rebamipide group (8 weeks) and the non-rebamipide group are compared through Wilcoxon singled rank test or paired test analysis for non-parametric test to analyze intestinal microbiota data of test group and control group. -For the intestinal microbiota, by comparing and analyzing the results of distribution of the intestinal microbiota before drug administration and 8 weeks after administration, the diversity of microbial community between the two groups will be analyzed by calculating alpha diversity and beta diversity, which means the diversity among individuals

Secondary Outcome Measures

Name	Time	Method
3-1) Primary Efficacy Endpoints -Comparison in terms of improvement in the symptoms of gastritis between the rebamipide group and the non-rebamipide group after an 8-week treatment 3-2) Secondary Efficacy Endpoints -Comparison in terms of change in the intestinal microbiota analyzed with 16S rRNA sequencing between the rebamipide group and the non-rebamipide group after an 8-week treatment