Fecal Microbiota Transplantation (FMT): PRIM-DJ2727
|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: NCT03786900|
Expanded Access Status : Available
First Posted : December 26, 2018
Last Update Posted : December 26, 2018
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.
|Condition or disease||Intervention/treatment|
|Recurrent Clostridium Difficile Infection Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection||Biological: Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727|
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|See clinical trials of the intervention/treatment in this expanded access record.|
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): NCT03786900
|Contact: Herbert L DuPont, MD||713 500 firstname.lastname@example.org|
|Contact: Zhi-Dong Jiang, MD, DrPHemail@example.com|
|Principal Investigator:||Herbert DuPont, MD||The University of Texas Health Science Center, Houston|