Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03399188|
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases||Procedure: Fecal microbiome transplantation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Inflammatory bowel disease patients in active stage.|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients|
|Actual Study Start Date :||November 15, 2017|
|Estimated Primary Completion Date :||November 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: FMT group
Group who received fecal microbiome transplantation
Procedure: Fecal microbiome transplantation
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.
- Clinical remission [ Time Frame: 6months after the Second FMT ]
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
- Microbiome analysis by using relative abundance at phylum and genus level, beta diversity [ Time Frame: Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT ]
- 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)
- Clinical response using disease activity index [ Time Frame: 6 months after the Second FMT ]
- Endoscopic healing [ Time Frame: 4 weeks after the First FMT ]
- Adverse events [ Time Frame: 6 months after the Second FMT ]Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399188
|Korea, Republic of|
|Seoul, Korea, Republic of, 03722|
|Contact: Hong Koh 82-2-2227-2050 firstname.lastname@example.org|