Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

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

Detailed Description
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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.

Official Title
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Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Procedure: Fecal microbiome transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 7 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Inflammatory bowel disease patients in active stage.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT group<br>Group who received fecal microbiome transplantation | Procedure: Fecal microbiome transplantation<br>* Fecal microbiota transplantation will be performed through colonoscopy to the IBD patients. Donor feces will be extensively screened for other diseases. Colonoscopy will be done at FMT center of Severance Children's Hospital twice with a month of duration. Recipients will be admitted the day before colonoscopy, and they will be discharged after a day of observation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | For Ulcerative Colitis patients Patients 18 years old and under: Pediatric ulcerative colitis activity index (PUCAI) less than 10. It ranges from 0 to 85, with a higher score indicating greater severity of disease Patients over 18 years old: Partial Mayo score same or less than 1 It ranges from 0 to 9, with a higher score indicating greater severity of disease For Crohn's Disease patients Patients 18 years old and under: Pediatric Crohn's disease activity index (PCDAI) less than 10 It ranges from 0 to 100, with a higher score indicating greater severity of disease Patients over 18 years old: Crohn's disease activity index (CDAI) less than 150 It ranges from 0 to over 600, with a higher score indicating greater severity of disease | 6months after the Second FMT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome analysis by using relative abundance at phylum and genus level, beta diversity | Microbial changes (increase of microbial diversity and improvement of firmicutes/bacteriodes ratio) in an early stage after FMT by using Relative abundance at phylum and genus level Microbial stability after FMT for one week (change in beta diversity) | Before, day 0 28 of 1st FMT, day 0 28, 60, 90, 180 of 2nd FMT | 
| Clinical response using disease activity index |  | 6 months after the Second FMT | 
| Endoscopic healing |  | 4 weeks after the First FMT | 
| Adverse events | Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT. | 6 months after the Second FMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome