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Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

Primary Purpose

Recurrent Clostridium Difficile Infection, Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727
Sponsored by
Herbert DuPont, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Recurrent Clostridium Difficile Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 11, 2018
    Last Updated
    May 23, 2023
    Sponsor
    Herbert DuPont, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03786900
    Brief Title
    Fecal Microbiota Transplantation (FMT): PRIM-DJ2727
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Herbert DuPont, MD

    4. Oversight

    5. Study Description

    Brief Summary
    The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool from a healthy, screened donor. Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or phone call. A screening list for donors will be provided to make sure that the list fits the requestor's requirements. A basic fee will be requested to recover the cost of making the product. After an agreement is made, a contract will be signed between the 2 parties. A week before the treatment, requestors will contact the study team for possible FMT product delivery. Delivery method will be confirmed for delivery by personnel (within 10 minutes driving distance) or by using FedEx services. Each delivered product will have an approved delivery form signed and dated by both the person who prepared the delivery and the person who received the package.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Clostridium Difficile Infection, Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727

    10. Eligibility

    Eligibility Criteria
    Inclusion Criteria: - Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Herbert L DuPont, MD
    Phone
    713 500 9366
    Email
    herbert.l.dupont@uth.tmc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhi-Dong Jiang, MD, DrPH
    Phone
    713-500-9371
    Email
    zhi-dong.jiang@uth.tmc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Herbert DuPont, MD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

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