Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

May 23, 2023 updated by: Herbert DuPont, MD

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

-

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herbert DuPont, MD

Investigators

  • Principal Investigator: Herbert DuPont, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SPH-15-0991

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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