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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

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

NCT ID

NCT03786900

First Posted

December 11, 2018

Last Updated

May 23, 2023

Sponsor

Herbert DuPont, MD

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

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

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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