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 22, 2018
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Condition or disease | Intervention/treatment | Phase |
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Ulcerative Colitis | Biological: Fecal Microbiota Transplantation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: Fecal Microbiota Transplantation
Individuals with Ulcerative Colitis will undergo a fecal microbiota transplantation.
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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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with biopsy proven ulcerative colitis (UC), including those with inadequately controlled UC (flare) as defined by failure of standard medical therapy, steroid-dependence, and/or need for escalation of medical care as determined by severity index (Mayo Score), endoscopic or histologic study, and/or medical provider
- Have active disease, defined with a Mayo Score > 3 and Mayo endoscopic subscore >1
- Subjects whom the investigator believes can and will comply with the requirements of the protocol
- Able to provide informed written consent.
Exclusion Criteria:
- Biopsy-proven Crohn's disease or indeterminate colitis
- Acute abdomen or other clinical emergencies requiring emergent management (for example: stricture, bowel obstruction, perforation and/or abscess)
- Primary sclerosing cholangitis (PSC)
- Pregnancy
- Concurrent Clostridium difficile infection or other known infection
- Prior history of fecal microbiota transplantation
- Other causes of diarrhea, including but not limited to tube feeds and medications (for example, kayaxelate, metformin, lactulose, laxatives, magnesium)
- Major congenital defects
- Subjects with recent malignancy in the last 5 years, excluding non-melanoma skin malignancies
- Anaphylactic reactions to any foods
- Any antibiotic use within the last 3 months
- Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant participating in the study, would make it unlikely for the participant to complete the study, or would confound the study

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT02516384 |
Other Study ID Numbers: |
1404014982 |
First Posted: | August 5, 2015 Key Record Dates |
Last Update Posted: | February 22, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Fecal Microbiota Transplantation Ulcerative Colitis |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |