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Fecal Microbiota Transplant

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. Identifier: NCT04090346
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2019
Last Update Posted : January 2, 2020
Information provided by (Responsible Party):
Methodist Health System

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE June 5, 2018
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • treatment date [ Time Frame: eight weeks following transplant. ]
    date of treatment
  • material volume [ Time Frame: eight weeks following transplant. ]
    volume of material
  • severity and type of CDI [ Time Frame: eight weeks following transplant. ]
    severity and type of CDI
  • serious adverse reactions [ Time Frame: eight weeks following transplant. ]
    serious adverse reactions
  • repeat transplant, colectomy and antibiotics [ Time Frame: eight weeks following transplant. ]
    patients who require additional treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplant
Official Title  ICMJE Fecal Microbiota Transplant
Brief Summary

The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection.

Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a carefully screened donor is inserted into the colon of a compromised patient. FMT is a procedure to replace beneficial bacteria that has been killed or suppressed, most commonly by use of antibiotics. Currently it is utilized as an experimental treatment for Clostridium difficile infection (CDI). This procedure is predicted to reduce the cost both financially and physically for the CDI patient and facility.

Detailed Description

Methodist Health System wishes to offer transplant services to our CDI populations which meet all criteria for recurrent intractable disease. The objective is to reduce the cost both financially and physically to patients and the facility, of living with chronic or recurrent CDI disease. This study is to provide treatment and demonstrate documented outcomes and success rates in a manner that protects both the patients and the facility. Of note this treatment is currently being provided by many facilities in Texas, under the FDA Investigational New Drug (IND) enforcement discretion.

The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. This study will only examine FMT as it is the only available therapy beyond antibiotic treatment. When patients are considered for FMT they have already failed traditional therapeutic medications.

Patients will be required to meet a specified criteria set forth for chronic or severe CDI infection. Chronic infection is defined as the third or greater episode of C Difficile infection, proven by a positive stool assay with previous documented treatments. Patients must be first treated with first line drug therapies which include vancomycin, metronidazole or fidaxomicin without cure. They must have been treated with at least one course of drugs over a six to eight week period of a vancomycin taper or vancomycin treatment followed by rifaximin for two weeks. Severe CDI infection is defined as refractory moderate to severe CDI diarrhea, with failing vancomycin drug therapy.

Patients with contraindicated co-morbidities will be excluded. Comorbidities include severe bowel disease which would preclude colonoscopy, severe underlying immune suppression or decompensated liver cirrhosis.

Patients will be under the care of a physician who is an identified investigator (sub-investigator) of this study for preparation, procedure and follow up care. Patients will be counseled by this physician regarding the risks and side effects of the procedure and transplant. Staff will only reinforce details from written materials given to patients. Questions outside of the written materials will be directed to the investigators for follow up.

Risks include, but are not limited to the following.

  • Transplant making no improvement in the course of their CDI.
  • Common side effects including transient gas, bloating and rectal irritation
  • Surgical risks which can include blood clots, excessive bleeding, allergic reactions and death. More common surgical risks are infection, drug reactions, bleeding, and perforation.
  • Transmission of antibiotic-resistant bacteria: These are resistant to one or more antibiotics. These bacteria could be transmitted through FMT and cause a serious infection. The FMT that you will receive is provided by a company called OpenBiome, where donors who provide stool for the FMT treatments undergo screening for certain antibiotic-resistant bacteria and clinical risk factors that would make their exposure to antibiotic resistant bacteria more likely. Individuals who test positive for these bacteria or have these risk factors are excluded from donating.

Patients will sign three informed consents. The first consent is to acknowledge the basis of the treatment is part of a research study (exhibit 1). The second consent) specifies that FMT is experimental in nature, and reviews the potential risks and benefits of the transplant. The third is the Methodist Health System "Disclosure and Consent" that is used for colonoscopy procedures.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Clostridium Difficile Infection
Intervention  ICMJE Procedure: Fecal Microbiota Transplant
Fecal Microbiota Transplant (FMT) is a procedure to replace beneficial bacteria which has been killed or suppressed in the colon.
Other Name: FMT
Study Arms  ICMJE Experimental: Clostridium difficile infection
Clostridium difficile infection (CDI) is due to a toxin-producing bacteria that causes a more severe form of antibiotic associated diarrhea. The disease ranges from mild diarrhea to severe colon inflammation that can even be fatal.
Intervention: Procedure: Fecal Microbiota Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2026
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Recurring CDI after three episodes of mild to moderate C Diff infections and failure to respond to appropriate antimicrobial treatment of six to eight weeks.
  • Metronidazole
  • Vancomycin
  • At least two episodes of severe C diff infection that have required hospitalization and significant morbidity within one year
  • Severe C Diff infection requiring hospitalization and non- responsive to maximal medication therapy

Exclusion Criteria:

  • advanced Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
  • cirrhosis of the liver
  • recent bone marrow transplants
  • medication suppressed immune systems (allowed per physician discretion if benefit outweighs risk)
  • pregnancy
  • Toxic megacolon or ileus present
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04090346
Other Study ID Numbers  ICMJE 010.GID.2018.A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Methodist Health System
Study Sponsor  ICMJE Methodist Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muhammad Memon, MD Methodist Mansfield Medical Center
PRS Account Methodist Health System
Verification Date August 2019

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