Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Yonsei University
Updated on 22 January 2021
microbiota
ulcerative colitis
crohn's disease
enteropathy
fecal microbiota transplantation
colitis
ulceration

Summary

Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.

Description

Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently.

Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation.

Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.

Details
Condition Gastroenteritis, Gastroenteritis, Intestinal Diseases, Bowel Dysfunction, Inflammatory bowel disease, Inflammatory bowel disease, Bowel Dysfunction, inflammatory bowel diseases
Treatment Fecal microbiome transplantation
Clinical Study IdentifierNCT03399188
SponsorYonsei University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years old to 80 years old at start of trial
Inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and Behcet's colitis
Patients who do not respond to the conventional treatments or who do not wish/not able to use one
Patients who agree to participate in the trial after thorough explanation
Evidence of active disease

Exclusion Criteria

Patients whose CRP<8, calprotectin<200, and mucosal healing endoscopically (who are in stable state)
Patients whose symptom is due to other disease than IBD
_Patients with immunosuppressive disease
Patients who are clinically unstable such as massive hemorrhage or perforation
Patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction
Absolute neutrophil count (ANC) <1.5 10^9/L (1500/mm3)
Pregnant or under breast feeding
Patients enrolled in other clinical trials
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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