Clinical Efficacy and Safety of Fecal Microbiota Transplantation

Keimyung University

Status: Unknown

Conditions: Fecal Microbiota Transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT04900051

2020-08-016

Details and patient eligibility

About

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. .

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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