Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)
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|ClinicalTrials.gov Identifier: NCT02516384|
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Biological: Fecal Microbiota Transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||January 31, 2017|
Experimental: Fecal Microbiota Transplantation
Individuals with Ulcerative Colitis will undergo a fecal microbiota transplantation.
Biological: Fecal Microbiota Transplantation
We will use fecal microbiota transplantation (FMT), with fecal material obtained from OpenBiome or donor directed, to assess safety (as primary outcome) and efficacy (as secondary outcome) in adult (>18 year old) patients with active ulcerative colitis (UC).
- Safety post-FMT as determined by interview for adverse events [ Time Frame: 36 months post-FMT ]Patient information regarding adverse events and safety of FMT for UC will be collected throughout the study period, including day 0, weeks 1, 2, 4, 6, 12 24, and then every 6 months until 36 months post-FMT. Throughout the study period, patients will be assessed for safety with questions regarding general well-being (such as "how have you been feeling?"), as well as specific questions to evaluate for occurrence of adverse events. Patients will also be questioned regarding stool form and frequency, presence of abdominal pain, fevers and subjective well-being.
- Clinical remission [ Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation ]Defined by Mayo score ≤ 2 without any subscore >1, and Mayo endoscopic subscore 0-1
- Clinical Response [ Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation ]Defined by decrease in Mayo score by 3 points, decrease in bleeding subscore by 1, or absolute subscore of 0-1
- Progression of disease defined by initiation of anti-TNF agents [ Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation ]Initiation of anti-TNF agents (such as infliximab, adalimumab, certolizumab), vedolizumab, steroids. Includes time gap until additional agents are started
- Progression of disease defined by increase in dosages of current UC medications [ Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation ]Increase in dosages of current ulcerative colitis specific medications
- Progression of disease defined by time to colectomy [ Time Frame: up to three year follow-up period post fecal microbiota transplantation ]Time to colectomy rates and increase in time to colectomy
- Death secondary to UC [ Time Frame: Anytime during the three year follow-up period post fecal microbiota transplantation ]Time to death secondary to ulcerative colitis
- Progression of disease defined by clinical flare [ Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation ]Time to next flare
- Microbial changes [ Time Frame: 0, 2 and 4 weeks post fecal microbiota transplantation ]- Alterations in microbial profiles as defined by sequence of genetic material from fecal material.
- Immunological changes [ Time Frame: 0, 2 and 4 weeks post fecal microbiota transplantation ]- Alterations in immune cell function as defined by RNA sequencing and flow cytometry
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): NCT02516384
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Carl V Crawford, MD||Weill Medical College of Cornell University|