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Trial record 6 of 20 for:    fecal microbiota transplant uc

Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02516384
First Posted: August 5, 2015
Last Update Posted: November 1, 2016
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
July 29, 2015
August 5, 2015
November 1, 2016
July 2015
July 2019   (Final data collection date for primary outcome measure)
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.
  • Safety on day of FMT as determined by interview for adverse events [ Time Frame: Day of fecal microbiota transplantation ]
    Each patient will be given a diary to log adverse events and will be monitored for the occurrence of AEs, including SAEs, beginning immediately after FMT, on the day of the procedure.
  • Safety at 24 hours post-FMT as determined by interview for adverse events [ Time Frame: 24 hours post-FMT ]
    Patients will receive a telephone call at 24 hours post-FMT 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.
  • Safety at 1 week post-FMT as determined by interview for adverse events [ Time Frame: 1 week post-FMT ]
    Patients will receive a telephone call at 1 week post-FMT 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.
  • Safety at 2 weeks post-FMT as determined by interview and physical examination for adverse events [ Time Frame: 2 weeks post-FMT ]
    Patients will be seen at the physician's office for a physical examination and will be questioned regarding stool form and frequency, presence of abdominal pain, fevers and subjective well-being.
  • Safety at 4 weeks post-FMT as determined by interview and physical examination for adverse events [ Time Frame: 4 weeks post-FMT ]
    Patients will be seen at the physician's office for a physical examination and will be questioned regarding stool form and frequency, presence of abdominal pain, fevers and subjective well-being.
  • Safety at 6 weeks post-FMT as determined by interview for adverse events [ Time Frame: 6 weeks post-FMT ]
    Patients will receive a telephone call at 6 weeks post-FMT 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.
  • Safety at 12 weeks post-FMT as determined by interview and physical examination for adverse events [ Time Frame: 12 weeks post-FMT ]
    Patients will be seen at the physician's office for a physical examination and will be questioned regarding stool form and frequency, presence of abdominal pain, fevers and subjective well-being.
  • Safety at 24 weeks post-FMT as determined by interview for adverse events [ Time Frame: 24 weeks post-FMT ]
    Patients will receive a telephone call at 24 weeks post-FMT 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.
  • Safety at 12 months post-FMT as determined by interview for adverse events [ Time Frame: 12 months post-FMT ]
    Patients will receive a telephone call at 12 months post-FMT 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.
  • Safety at 18 months post-FMT as determined by interview for adverse events [ Time Frame: 18 months post-FMT ]
    Patients will receive a telephone call at 18 months post-FMT 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.
  • Safety at 24 months post-FMT as determined by interview for adverse events [ Time Frame: 24 months post-FMT ]
    Patients will receive a telephone call at 24 months post-FMT 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.
  • Safety at 30 months post-FMT as determined by interview for adverse events [ Time Frame: 30 months post-FMT ]
    Patients will receive a telephone call at 30 months post-FMT 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.
  • Safety at 36 months post-FMT as determined by interview for adverse events [ Time Frame: 36 months post-FMT ]
    Patients will receive a telephone call at 36 months post-FMT 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.
Complete list of historical versions of study NCT02516384 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)
Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)
Inflammatory bowel disease is a condition caused by gastrointestinal immune system dysregulation and affected by both genetic and environmental factors. Differences in intestinal bacteria exist between IBD patients and healthy controls, but the role of intestinal bacteria in the development and treatment of IBD remains largely unknown. Fecal microbiota transplantation (FMT) is the transfer of gastrointestinal bacteria from a healthy donor to a patient with altered microbial diversity with the intent of restoring a normal bacterial balance. Most studies focus on its use in treating Clostridium difficile (CDI), an infection characterized by dysbiosis. Given the role of dysbiosis in IBD, the investigators hypothesize that FMT may be beneficial in IBD. The purpose of this study is to prospectively examine the safety of FMT in the management of ulcerative colitis (UC).
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) with significant morbidity and mortality. Current therapies remain limited by side effects and loss of response over time, and there is an ongoing need for new therapies. Fecal microbiota transplantation (FMT), which has proven to be safe and effective in the management of Clostridium difficile infection (CDI) has been proposed as a therapy for UC. There have been studies examining the role of FMT in UC, but they have shown mixed results, and have not examined the underlying immunologic and microbial changes to explain how and why FMT works from specific donors and in certain recipients. Furthermore, no studies have examined the long-term safety of FMT in patients with UC. This proposal aims to examine: (a) the short- and long-term safety of FMT in patients with UC, (b) the efficacy of FMT as a therapy for mild-moderate UC, and (c) the microbial and immunologic changes that occur after FMT, to help understand how and why it works in this group of patients.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ulcerative Colitis
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).
Experimental: Fecal Microbiota Transplantation
Individuals with Ulcerative Colitis will undergo a fecal microbiota transplantation.
Intervention: Biological: Fecal Microbiota Transplantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2019
July 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02516384
1404014982
Yes
Not Provided
Plan to Share IPD: No
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Carl V Crawford, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP