Recurrent C. Difficile InfectionPhase 2NCT03298048
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
A Phase 2 study testing Low fecal microbiota dose, Mid fecal microbiota dose and High fecal microbiota dose in people with Recurrent C. Difficile Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Recurrent C. Difficile Infection
- What is being tested?
- Low fecal microbiota dose, Mid fecal microbiota dose and High fecal microbiota dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2017to 30 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
- Female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure.
- Subject willing to sign an informed consent form
- Subject deemed likely to survive for ≥ 1 year after enrollment
- Able to follow study procedure and follow-ups
- Subjects' attending physician will provide non-transplant care for the subject
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- Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin
- Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of vancomycin or metronidazole or fidaxomicin) since last bout of CDI
- Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for overnight
Who cannot join
- Unable to take capsules orally
- Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT
- Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other than that found in fortified foods
- Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT
- Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Phase II. Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
Read the detailed description
This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.
- Conditions
- Recurrent C. Difficile Infection
- Being tested
- Low fecal microbiota dose, Mid fecal microbiota dose, High fecal microbiota dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fecal microbiota doseBiological
Also called Fecal microbiota transplantation (FMT)
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Mid fecal microbiota doseBiological
Also called Fecal microbiota transplantation (FMT)
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
High fecal microbiota doseBiological
Also called Fecal microbiota transplantation (FMT)
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Low fecal microbiota dose | Active comparator | receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days Receives: Biological: Low fecal microbiota dose |
| Mid fecal microbiota dose | Active comparator | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment Receives: Biological: Mid fecal microbiota dose |
| High fecal microbiota dose | Active comparator | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days Receives: Biological: High fecal microbiota dose |
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 Nausea
Measured: 180 days
Safety as Assessed by Number of Participants With Vomiting
Measured: 180 days
Safety as Assessed by Number of Participants With Diarrhea
Measured: 180 days
Safety as Assessed by Number of Participants With Bloating
Measured: 180 days
Safety as Assessed by Number of Participants With Constipation
Measured: 180 days
Secondary outcomes (1)
Number of Participants With Recurrent C. Difficile Infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start21 Dec 2017
- Primary completion30 Mar 2019
- Study completion30 Jun 2019
Why it stopped: Investigators are no longer considering FMT product development for C. difficile.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent C. Difficile InfectionStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herbert DuPont, The University of Texas Health Science Center, Houston
- Investigators
- Herbert L DuPont, MD, Principal investigator, UTHealth School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298048
- Sponsor's protocol ID
- HSC-SPH-17-0614
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2017
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II. Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
- ClinicalTrials.gov ID
- NCT03298048
- Acronym / sponsor ID
- HSC-SPH-17-0614
- Conditions
- Recurrent C. Difficile Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators are no longer considering FMT product development for C. difficile.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Posted 6 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
Detailed description
This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low fecal microbiota dose | Active comparator | Biological: Low fecal microbiota dosereceiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days |
| Mid fecal microbiota dose | Active comparator | Biological: Mid fecal microbiota dosereceiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment |
| High fecal microbiota dose | Active comparator | Biological: High fecal microbiota dosereceiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
- Female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure.
- Subject willing to sign an informed consent form
- Subject deemed likely to survive for ≥ 1 year after enrollment
- Able to follow study procedure and follow-ups
Key exclusion criteria (5 listed)
- Unable to take capsules orally
- Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT
- Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other than that found in fortified foods
- Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT
- Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
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 |
|---|---|---|
| Low fecal microbiota doseAlso: Fecal microbiota transplantation (FMT)receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days | Biological | Low fecal microbiota dose |
| Mid fecal microbiota doseAlso: Fecal microbiota transplantation (FMT)receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment | Biological | Mid fecal microbiota dose |
| High fecal microbiota doseAlso: Fecal microbiota transplantation (FMT)receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days | Biological | High fecal microbiota dose |
Primary outcome
Safety as Assessed by Number of Participants With Nausea
Time frame: 180 days
Safety as Assessed by Number of Participants With Vomiting
Time frame: 180 days
Safety as Assessed by Number of Participants With Diarrhea
Time frame: 180 days
Safety as Assessed by Number of Participants With Bloating
Time frame: 180 days
Safety as Assessed by Number of Participants With Constipation
Time frame: 180 days
1 secondary outcome
Number of Participants With Recurrent C. Difficile Infection
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Recurrent C. Difficile Infection
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
RecruitingPhase 2
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Clostridioides Difficile Infection
Active, not recruitingPhase 2/3
LMN-201 for Prevention of C. Difficile Infection Recurrence
Clostridioides Difficile Infection
RecruitingPhase 3
Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Clostridia Difficile Colitis
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 principal investigator
UTHealth School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low fecal microbiota dose, Mid fecal microbiota dose and High fecal microbiota dose in people with Recurrent C. Difficile Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Nausea (time frame: 180 days). The study lists 5 primary outcomes in all. 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 6 Mar 2020.