Clinical Efficacy and Safety of Fecal Microbiota Transplantation

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. .

Study Overview

• Status: Recruiting
• Conditions: Fecal Microbiota Transplantation

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yoo Jin Lee, Professor; Phone Number: +82-53-250-7163; Email: doctorlyj@naver.com

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daegu, Jung-gu, Korea, Republic of, 700-712
      • Recruiting
      • KeimyungUniversity
      • Contact: Yoo Jin Lee; Phone Number: +82-250-7088; Email: doctorlyj@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Hospitalized and outpatient aged from 18 to 80 years old
• Those who agrees after hearing the explanation on the efficacy and safety of fecal microbiota transplantation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Set up a FMT registry	Set up a registry of FMT in diseases known to be associated with intestinal microbial imbalance	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Investigators: Principal Investigator: Lee Yoo Jin, Professor, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-08-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No