Clinical trial NCT04900051: Clinical Efficacy and Safety of Fecal Microbiota Transplantation
Official title: Clinical Efficacy and Safety of Fecal Microbiota Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fecal Microbiota Transplantation
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Set up a FMT registry
timeFrame: 3 years
Secondary outcomes:
measure: Patient outcome of FMT
timeFrame: 6 month
measure: Developing biobank of FMT
timeFrame: 3 Years
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: KeimyungUniversity
state: Jung-gu
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Lee Yoo Jin, Professor
role: PRINCIPAL_INVESTIGATOR
References: