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
About this trial
This is an expanded access trial for Recurrent Clostridium Difficile Infection
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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