Clinical Efficacy and Safety of Fecal Microbiota Transplantation

• Conditions: Fecal Microbiota Transplantation

• Registration Number: NCT04900051
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief 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

Study Timeline

• Study Start: 2020-12-24
• Status Verified: 2021-03
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Those who have been diagnosed with disease to be studied and do not respond to exist treatments

  1. Ulcerative colitis, Crohn disease : Patient who does not responding to anti- TNF treatment for more than 3 month.
  2. Irritable bowel syndrome, Functional dyspepsia : Patient who does not responding to pharmacological therapies and serotonin uptake inhibitor for more than 6 month.
  3. Recurrent of Refractory CDI, NASH, Obesity : Patient who does not responding to treatment for more than 6 month.

Exclusion Criteria

• Neutrophil (<0.5 x 10*9/L)
• Leukocytosis (> 30.0 x 10*9/L)
• Toxic megacolon confirmed in abdomen Xray
• Pregnant or lactating women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Set up a FMT registry	3 years	Set up a registry of FMT in diseases known to be associated with intestinal microbial imbalance

Secondary Outcome Measures

Name	Time	Method
Patient outcome of FMT	6 month	Compare the severity of diseases, any adverse event before and after FMT
Developing biobank of FMT	3 Years	Collect the study sample of microbium from donors and recipients

Trial Locations

Locations (1)

KeimyungUniversity; 🇰🇷 Daegu, Jung-gu, Korea, Republic of