NCT04900051

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. .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 25, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

March 31, 2021

Last Update Submit

May 19, 2021

Conditions

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

  • Set up a FMT registry

    Set up a registry of FMT in diseases known to be associated with intestinal microbial imbalance

    3 years

Secondary Outcomes (2)

  • Patient outcome of FMT

    6 month

  • Developing biobank of FMT

    3 Years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Those who have been diagnosed with disease to be studied and do not respond to exist treatments
  • Ulcerative colitis, Crohn disease : Patient who does not responding to anti- TNF treatment for more than 3 month.
  • Irritable bowel syndrome, Functional dyspepsia : Patient who does not responding to pharmacological therapies and serotonin uptake inhibitor for more than 6 month.
  • Recurrent of Refractory CDI, NASH, Obesity : Patient who does not responding to treatment for more than 6 month.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KeimyungUniversity

Daegu, Jung-gu, 700-712, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood laboratory test(CBC, CRP, protein/albumin, AST/ALT, GTP, Total bilirubin/Direct bilirubin), Fecal calprotectin, Stool

Study Officials

  • Lee Yoo Jin, Professor

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoo Jin Lee, Professor

CONTACT

+82-53-250-7163doctorlyj@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 31, 2021

First Posted

May 25, 2021

Study Start

December 24, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)