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NCT03786900 Clinical Trial

Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

Recurrent Clostridium Difficile Infection Clinical Trial

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT03786900
Other study ID # HSC-SPH-15-0991
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date May 2023
Source The University of Texas Health Science Center, Houston
Contact Herbert L DuPont, MD
Phone 713 500 9366
Email herbert.l.dupont@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Herbert DuPont, MD
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