Clostridium DifficilePhase 2FMTNCT04729790
Randomized Clinical Trial of Standard FMT Treatments
A Phase 2 study testing PRIM-DJ2727 in people with Clostridium Difficile, run by The University of Texas Health Science Center, Houston.
Trial summary
This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- PRIM-DJ2727
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2020to 30 Apr 2022
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 years of age or older.
- Sexually active male and female subjects of childbearing potential agree to use an effective method of birth control during the study.
- Female subjects of childbearing potential will be asked if they could be pregnant. If the subject is unsure a pregnancy test will be completed
- Subject/LAR willing and able to provide informed consent.
- Able to follow study procedures and complete the follow-up questionnaire for safety.
- Subject must have an attending physician who will provide non-transplant care (Either PI of this study or referring physician).
- Medical history of ≥ 3 bouts of CDI in outpatient or ≥ 2 bouts of CDI in inpatient with either group having ≥ 2 positive fecal tests for C. difficile toxin and at least one bout of CDI within 6 months of enrollment.
- Received at least two courses of standard-of-care antibiotic therapy for CDI.
Who cannot join
- Unable to take capsules orally.
- Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT.
- Unwilling to stop taking non-dietary probiotics 24-96 hours prior to FMT.
- Unable to stop taking bile acid sequestrants (e.g. cholestyramine) 24-96 hours prior to FMT.
- Unable to stop use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide 24-96 hours prior to FMT and after FMT.
- Receipt of CDI monoclonal antibodies as treatment for the most recent bout of CDI.
- Life expectancy of < 6 months.
- In the opinion of investigator, subject for any reason, should be excluded from the study.
About this study
Official title: Phase II Randomized Clinical Trial of Standard FMT Treatments: Non-powered Pilot Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (RCDI) Using Either Single or Three Combined Products From Healthy Donors
This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from either single or three donors (group 1 receiving healthy microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving healthy microbiota collected from three donors 90g stool for 2 consecutive days). All subjects will be followed for approximately 180 days following FMT treatment for safety.
Read the detailed description
The endpoints of the study are to evaluate the efficacy and safety of lyophilized product by capsules obtained either from single or three donors and the prevention of subsequent bouts of CDI in 60 days post FMT.
- Conditions
- Clostridium Difficile
- Being tested
- PRIM-DJ2727
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIM-DJ2727Drug
oral FMT capsules
| Study group | Role | What they receive |
|---|---|---|
| Patients with RCDI will receive FMT capsules from single donor | Active comparator | Capsules made with intestinal bacteria from single healthy donor
1. st treatment day, lyophilized product generated from single donor (90g of stool)
2. nd treatment day, lyophilized product generated from single donor (90g of stool) Receives: Drug: PRIM-DJ2727 |
| Patient will receive FMT capsules from three donors | Experimental | Capsules made of intestinal bacteria from three healthy donors
1. st treatment day, lyophilized product generated from three donors (90g of stool)
2. nd treatment day, lyophilized product generated from three donors (90g of stool) Receives: Drug: PRIM-DJ2727 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by number of participants with treatment-related adverse events
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start10 Jan 2020 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Why it stopped: No Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blinded study for the groups randomized to receive FMT products either from single or three healthy donors
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herbert DuPont, MD, The University of Texas Health Science Center, Houston
- Investigators
- Herbert l DuPont, MD, Study director, University of Texas Health Science Center School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729790
- Sponsor's protocol ID
- HSC-SPH-19-0950
- Acronym
- FMT
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Clinical Trial of Standard FMT Treatments: Non-powered Pilot Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (RCDI) Using Either Single or Three Combined Products From Healthy Donors
- ClinicalTrials.gov ID
- NCT04729790
- Acronym / sponsor ID
- FMT / HSC-SPH-19-0950
- Conditions
- Clostridium Difficile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 10 Jan 2020 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 29 Jan 2021 (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.
This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from either single or three donors (group 1 receiving healthy microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving healthy microbiota collected from three donors 90g stool for 2 consecutive days). All subjects will be followed for approximately 180 days following FMT treatment for safety.
Detailed description
The endpoints of the study are to evaluate the efficacy and safety of lyophilized product by capsules obtained either from single or three donors and the prevention of subsequent bouts of CDI in 60 days post FMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blinded study for the groups randomized to receive FMT products either from single or three healthy donors
| Arm | Type | Receives |
|---|---|---|
| Patients with RCDI will receive FMT capsules from single donor | Active comparator | Drug: PRIM-DJ2727Capsules made with intestinal bacteria from single healthy donor 1. st treatment day, lyophilized product generated from single donor (90g of stool) 2. nd treatment day, lyophilized product generated from single donor (90g of stool) |
| Patient will receive FMT capsules from three donors | Experimental | Drug: PRIM-DJ2727Capsules made of intestinal bacteria from three healthy donors 1. st treatment day, lyophilized product generated from three donors (90g of stool) 2. nd treatment day, lyophilized product generated from three donors (90g of stool) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects 18 years of age or older.
- Sexually active male and female subjects of childbearing potential agree to use an effective method of birth control during the study.
- Female subjects of childbearing potential will be asked if they could be pregnant. If the subject is unsure a pregnancy test will be completed
- Subject/LAR willing and able to provide informed consent.
- Able to follow study procedures and complete the follow-up questionnaire for safety.
Key exclusion criteria (8 listed)
- Unable to take capsules orally.
- Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT.
- Unwilling to stop taking non-dietary probiotics 24-96 hours prior to FMT.
- Unable to stop taking bile acid sequestrants (e.g. cholestyramine) 24-96 hours prior to FMT.
- Unable to stop use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide 24-96 hours prior to FMT and after FMT.
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 |
|---|---|---|
| PRIM-DJ2727oral FMT capsules | Drug | Patient will receive FMT capsules from three donors, Patients with RCDI will receive FMT capsules from single donor |
Primary outcome
Safety as assessed by number of participants with treatment-related adverse events
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Clostridium Difficile
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
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 l DuPont, MD study director
University of Texas Health Science Center School of Public Health
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRIM-DJ2727 in people with Clostridium Difficile, run by The University of Texas Health Science Center, Houston.
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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 29 Jan 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by number of participants with treatment-related adverse events (time frame: 60 days). It is what the study was designed to measure, not a finding.
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 29 Jan 2021.