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Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT group | Experimental | Group who received fecal microbiome transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiome transplantation | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome analysis by using relative abundance at phylum and genus level, beta diversity |
| Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT |
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Inclusion Criteria:
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Recruiting | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Inflammatory bowel disease patients in active stage.
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| 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 |