Recurrent Clostridium Difficile InfectionNCT03786900
Fecal Microbiota Transplantation (FMT): PRIM-DJ2727
A study testing Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 in people with Recurrent Clostridium Difficile Infection and Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection, run by Herbert DuPont, MD.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Clostridium Difficile Infection, Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection
- What is being tested?
- Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Recurrent Clostridium Difficile Infection, Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection
- Being tested
- Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Herbert DuPont, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Herbert DuPont, MD, The University of Texas Health Science Center, Houston
- Investigators
- Herbert DuPont, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786900
- Sponsor's protocol ID
- HSC-SPH-15-0991
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2018
- Last updated
- 9 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation (FMT): PRIM-DJ2727
- ClinicalTrials.gov ID
- NCT03786900
- Acronym / sponsor ID
- HSC-SPH-15-0991
- Conditions
- Recurrent Clostridium Difficile Infection, Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Herbert DuPont, MDUniversity, hospital or other
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert DuPont, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 in people with Recurrent Clostridium Difficile Infection and Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection, run by Herbert DuPont, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herbert L DuPont, MD (713 500 9366, herbert.l.dupont@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.