None listed
Conditions
Interventions
Drug : 3 times a day, 1 tablet Mucosta 100mg orally administered for 8 weeks
This drug can be administered regardless of meals.
Investigational drugs are administered orally with 100 mg of Mucost
the rebamipide group will be treated with rebamipide for 8 weeks.
- Rebamipide is an approved drug for oral administration of 100mg once, 3 times a day for the treatment of gastritis. In this study, t
Sponsors
Jeonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public Contactseung ok Lee
Jeonbuk National University Hospital
Outcome results
None listed