Clinical Efficacy and Safety of Fecal Microbiota Transplantation

Fecal Microbiota Transplantation Clinical Trial

Official title:

Clinical Efficacy and Safety of Fecal Microbiota Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900051
• Other study ID #: 2020-08-016
• Status: Recruiting
• Start date: December 24, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Keimyung University Dongsan Medical Center
• Contact: Yoo Jin Lee, Professor
• Phone: +82-53-250-7163
• Email: doctorlyj[@]naver.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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. .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation

Locations

Country	Name	City	State
Korea, Republic of	KeimyungUniversity	Daegu	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Set up a FMT registry	Set up a registry of FMT in diseases known to be associated with intestinal microbial imbalance	3 years
Secondary	Patient outcome of FMT	Compare the severity of diseases, any adverse event before and after FMT	6 month
Secondary	Developing biobank of FMT	Collect the study sample of microbium from donors and recipients	3 Years