Fecal Microbiota Transplantation in Pediatric Patients (FMT)
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|ClinicalTrials.gov Identifier: NCT02108821|
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases (IBD) Crohn's Disease (CD) Ulcerative Colitis (UC)||Biological: Fecal Microbiota Transplantation (FMT)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease.|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||May 30, 2017|
|Actual Study Completion Date :||July 11, 2017|
Experimental: Fecal Microbiome Transplantation
Fecal Microbiome Transplantation will be done at the time of EGD and colonoscopy. A parent or sibling or a healthy relative will be tested for several infections like hepatitis, H. Pylori, HIV, syphilis, ova and parasites, culture and C.diff. They will fill out a donor questionnaire used for blood donors prior to the sample collection. After eligibility criteria have been met, appropriate consent has been obtained, and the screening labs have been assessed, the fecal transplant procedure will take place in the procedure center at Children's Hospital of Pittsburgh. Fresh stool sample will be obtained from the donor. The fecal sample will be prepared for transplantation in a designated area in the procedure center. Frequency: once. Duration: Approximately 1 hour
Biological: Fecal Microbiota Transplantation (FMT)
The process of fecal microbiota transplantation (FMT), where fecal bacteria from a healthy individual is transferred into a recipient as an alternative therapy for individuals affected with these life-altering diseases: Crohn's Disease (CD), and/or Ulcerative Colitis (UC).
Other Name: Fecal Transplantation
- Primary Objective: Study the safety of Fecal Microbiome Transplantation in patients with Inflammatory Bowel Diseases by assessing change in fecal microbiome. [ Time Frame: 1 week, 1 month, and 6 months post Fecal Microbiome Transplantation. ]Correlate safety and patient outcomes with fecal microbiome prior to and after Fecal Microbiome Transplantation.
- Examine the efficacy of Fecal Microbiome Transplant in the treatment of children with IBD using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) analysis, and assessing the change. [ Time Frame: 1 week, 1 month, and 6 months post Fecal Microbiome Transplant. ]Examine the efficacy of Fecal Microbiome Transplantation in the treatment of children with IBD using the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity Index (PCDAI) analysis, and assessing the change in the PUCAI or the PCDAI analysis.
- Correlate the patient outcomes with the fecal microbiome prior to, and after Fecal Microbiome Transplantation. [ Time Frame: 1 week, 1 month, and 6 months post Fecal Microbiome Transplantation. ]Correlate the patient outcomes with the fecal microbiome prior to, and after Fecal Microbiome Transplantation.
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): NCT02108821
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Alka Goyal, MD||Children's Mercy Hospital Kansas City|