Recurrent Clostridium Difficile InfectionPhase 2NCT03973697
Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
A Phase 2 study testing Penn Microbiome Therapy - 001, Penn Microbiome Therapy - 002 and Penn Microbiome Therapy - 003 in people with Recurrent Clostridium Difficile Infection, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Clostridium Difficile Infection
- What is being tested?
- Penn Microbiome Therapy - 001, Penn Microbiome Therapy - 002 and Penn Microbiome Therapy - 003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline.
- Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
- At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
- Age ≥ 18 years.
- Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.
Who cannot join
- Evidence of colon/small bowel perforation at the time of study screening
- Goals of care are directed to comfort rather than curative measures.
- Moderate (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.
- Known food allergy that could lead to anaphylaxis.
- Pregnancy
- For subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration
- Meeting criteria for severe, severe-complicated/fulminant CDI within 24 hours of planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2) hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or requiring pressors; (3) provider documentation of ileus or radiologic evidence of bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum creatinine level by ≥50% or new dialysis initiation; (5) serum lactate > 2.2 mmol/L; or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) criteria (which include heart rate > 90 beats per minute, respiratory rate > 20 breaths per minute or PaCO2 < 32 mmHg, temperature >38ºC or <36ºC, WBC > 12,000 cells/uL, <4,000 cells/uL, or >10% immature (band) forms).
- Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the Univeristy of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection
This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).
- Being tested
- Penn Microbiome Therapy - 001, Penn Microbiome Therapy - 002, Penn Microbiome Therapy - 003
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penn Microbiome Therapy - 001Drug
Also called PMT-001
Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002Drug
Also called PMT-002
Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003Drug
Also called PMT-003
Fecal Microbiota for Transplant, capsule product
| Study group | Role | What they receive |
|---|---|---|
| Single dose of PMT | Experimental | Not described Receives: Drug: Penn Microbiome Therapy - 001; Drug: Penn Microbiome Therapy - 002; Drug: Penn Microbiome Therapy - 003 |
| Two doses of PMT | Experimental | Administered within 24 hours Receives: Drug: Penn Microbiome Therapy - 001; Drug: Penn Microbiome Therapy - 002; Drug: Penn Microbiome Therapy - 003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.
Clinical resolution will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT. Clinical resolution will be defined as follows:
- ≤ 4 stools per calendar day for the prior two days with no stool of Bristol stool scale type 7
- No additional stool tests with a positive EIA for C. difficile toxin since study enrollment
- No additional prescription or use of anti-CDI antibiotics (unless given for prophylaxis) since study enrollment
- No need for an additional
Measured: 8 weeks
Secondary outcomes (7)
All-cause Mortality at 30-days Following Last FMT
Measured: 30 days
All-cause Mortality at 60-days Following Last FMT
Measured: 60 days
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT
Measured: 30 days
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT
Measured: 30 days
Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT
Measured: 30 Days
Bacteremia From Enrollment Until 30 Days After Last FMT
Measured: 30 days
Hospital Admission Within 60 Days of Discharge From Index Hospitalization
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 posted4 Jun 2019
- Study start13 Jan 2020
- Primary completion11 Aug 2021
- Study completion31 Dec 2021
Why it stopped: Administrative reasons
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 Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Randomized, open label, comparative
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ebbing Lautenbach, MD, MPH, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973697
- Sponsor's protocol ID
- IRB # 832963
- Status last verified
- Oct 2023
- First submitted
- 17 Apr 2019
- Last updated
- 1 Nov 2023
- 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT03973697
- Acronym / sponsor ID
- IRB # 832963
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Posted 1 Nov 2023
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 randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open label, comparative
| Arm | Type | Receives |
|---|---|---|
| Single dose of PMT | Experimental | Drug: Penn Microbiome Therapy - 001, Drug: Penn Microbiome Therapy - 002, Drug: Penn Microbiome Therapy - 003 |
| Two doses of PMT | Experimental | Drug: Penn Microbiome Therapy - 001, Drug: Penn Microbiome Therapy - 002, Drug: Penn Microbiome Therapy - 003Administered within 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline.
- Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
- At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
- Age ≥ 18 years.
- Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.
Key exclusion criteria (8 listed)
- Evidence of colon/small bowel perforation at the time of study screening
- Goals of care are directed to comfort rather than curative measures.
- Moderate (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.
- Known food allergy that could lead to anaphylaxis.
- Pregnancy
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 |
|---|---|---|
| Penn Microbiome Therapy - 001Also: PMT-001Fecal Microbiota for Transplant, enema product | Drug | Single dose of PMT, Two doses of PMT |
| Penn Microbiome Therapy - 002Also: PMT-002Fecal Microbiota for Transplant, suspension product | Drug | Single dose of PMT, Two doses of PMT |
| Penn Microbiome Therapy - 003Also: PMT-003Fecal Microbiota for Transplant, capsule product | Drug | Single dose of PMT, Two doses of PMT |
Primary outcome
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.
Time frame: 8 weeks
Clinical resolution will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT. Clinical resolution will be defined as follows: * ≤ 4 stools per calendar day for the prior two days with no stool of Bristol stool scale type 7 * No additional stool tests with a positive EIA for C. difficile toxin since study enrollment * No additional prescription or use of anti-CDI antibiotics (unless given for prophylaxis) since study enrollment * No need for an additional
7 secondary outcomes
All-cause Mortality at 30-days Following Last FMT
Time frame: 30 days
All-cause Mortality at 60-days Following Last FMT
Time frame: 60 days
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT
Time frame: 30 days
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT
Time frame: 30 days
Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT
Time frame: 30 Days
Bacteremia From Enrollment Until 30 Days After Last FMT
Time frame: 30 days
Hospital Admission Within 60 Days of Discharge From Index Hospitalization
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ebbing Lautenbach, MD, MPH, MSCE principal investigator
University of Pennsylvania
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 Penn Microbiome Therapy - 001, Penn Microbiome Therapy - 002 and Penn Microbiome Therapy - 003 in people with Recurrent Clostridium Difficile Infection, run by University of Pennsylvania 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 5 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: stopped early, as of the sponsor's last update on 1 Nov 2023. 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 1 Nov 2023). 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?
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control. (time frame: 8 weeks). 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 1 Nov 2023.