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Trial record 14 of 96 for:    Recruiting Studies | fecal microbiota transplantation

Fecal Transplant for MDRO Decolonization

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04181112
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Amee Manges, University of British Columbia

Brief Summary:
This is a trial designed to determine whether fecal microbiota transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. The primary goal of this study is to test whether oral gut decontamination followed by FMT using enema delivery will result in decolonization of the intestinal tract of renal transplant patients shortly after solid organ transplantation, thereby preventing difficult to treat post-transplant infections.

Condition or disease Intervention/treatment Phase
Multi-antibiotic Resistance Biological: Fecal Microbiota Transplantation (FMT) Not Applicable

Detailed Description:
Contact the study principal investigator for the study protocol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation (FMT) for Intestinal Decolonization of Multidrug-resistant Opportunistic Pathogens
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Fecal microbiota transplantation Biological: Fecal Microbiota Transplantation (FMT)
FMT using retention enema

Experimental: Fecal microbiota transplantation with antibiotic pre-treatment Biological: Fecal Microbiota Transplantation (FMT)
FMT using retention enema

No Intervention: No intervention follow-up



Primary Outcome Measures :
  1. The elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Compare proportions, type and timing of adverse events post-FMT [ Time Frame: 3 years ]
  2. Proportions of recolonization over 180 days [ Time Frame: 3 years ]
  3. Timing of recolonization over 180 days [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Renal transplant patient inclusion criteria:

  • 18 years or older
  • Able to provide informed consent
  • Positive for one of the target MDRO by rectal or stool culture tests

FMT stool donor inclusion criteria:

  • Able to provide informed consent
  • Able to complete donor screening
  • Able to adhere to FMT stool collection and testing procedures

Renal transplant patient exclusion criteria:

  • Still in hospital at week 7 following organ transplantation
  • Pregnant or planning to become pregnant
  • Breastfeeding
  • Participating in another interventional or investigational study
  • Neutropenic (ANC < 0.5)
  • Presence of colostomy or ileostomy
  • Has an active intestinal infection
  • Fever > 38.0 or white blood count (WBC) count > 15,000
  • Are taking a non-dietary probiotic supplement
  • Require or are expected to require systemic antimicrobial therapy other than Pneumocystis prophylaxis or cytomegalovirus (CMV) therapy during the study period
  • Has a severe underlying disease with anticipated survival less than 6 months
  • Are unable to tolerate FMT or enema for any reason, or where their physician believes for any reason that FMT might pose a health risk to the subject
  • Subjects who report a history of anaphylactoid food allergy will not be excluded but these allergies will be noted and donors will be required to avoid ingestion of these foods for at least three days prior to donation

FMT stool donor exclusion criteria:

  • Presence of any of the following by stool examination: vancomycin-resistant Enterococci (VRE), Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia, Campylobacter, extended spectrum beta-lactamase (ESBL) producing organisms or carbapenemase-producing Enterobacteriaceae (CRE), pathogenic ova or parasites, C. difficile toxin B (by PCR), or rotavirus, adenovirus and norovirus
  • History of any type of active cancer aside from melanoma
  • Risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire
  • History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea, or colostomy or ileostomy
  • Receipt of blood transfusion from a country other than Canada in the preceding 6 months
  • Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
  • Receipt of any live vaccine within 3 months prior to stool donation
  • Any current or previous medical or psychosocial condition or behaviors which in the opinion of the investigator may pose risk to the recipients or the donor

Information from the National Library of Medicine

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): NCT04181112


Contacts
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Contact: Amee Manges, MPH, PhD 604 707 2743 amee.manges@ubc.ca

Locations
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Canada, British Columbia
Providence Health Care - St. Paul's Hospital Active, not recruiting
Vancouver, British Columbia, Canada
Vancouver Coastal Health - Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Theodore Steiner, MD         
Sponsors and Collaborators
University of British Columbia

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Responsible Party: Amee Manges, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04181112    
Other Study ID Numbers: H19-00782 FMT.MDRO.RCT.1
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amee Manges, University of British Columbia:
Fecal Microbiota Transplantation