NCT04900051

Clinical Efficacy and Safety of Fecal Microbiota Transplantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Keimyung University Dongsan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Changes in the fecal microbiota are known to be involved in the etiology of several diseases. The purpose of this study is to evaluate the effectiveness and safety of fecal microbiota transplantation (FMT) in diseases known to be associated with intestinal microbial inbalance. .

Detailed description

This registry will prospectively enroll 300 patients who undergo fecal microbiota transplantation(FMT) at 3 clinical center (Yeungnam university mecial center, Kyungpook national university hospital, Keimyung university dongsan medical center). Feces received from healthy donors are prepared as frozen feces according to a standardized protocol, and transplanted to recipients within 3 months. Next generation sequencing(NGS) is used to check the characteristics of the fecal microbiota of the donor stool, and to evaluate the efficacy by checking the change in the fecal microbium of recipient before and after transplantation. The data is documented for following diseases known to be related to microbium imbalance. 1. Recurrent or Refractory CDI Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin) 2. Irritable bowel syndrome, Functional dyspepsia Abdominal symptoms questionnaires, IBS diagnosis and food-related questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin) 3. Inflammatory Bowel Disease Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), fecal calprotectin, Colonoscopic examination(Mayo endoscopic subscore, CD-SES) 4. Non-alcoholic steatohepatitis, NASH Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), BMI check 5. Obesity Abdominal symptoms questionnaires, blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), BMI check

Conditions

• Fecal Microbiota Transplantation

Timeline

• Start date: 2020-12-24
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-05-25
• Last updated: 2021-05-25

Locations

1 site across 1 country: South Korea