TerminatedNCT03973697Updated Nov 1, 2023Results posted

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

A Phase 2 interventional study of Penn Microbiome Therapy - 001 and Penn Microbiome Therapy - 002 in Recurrent Clostridium Difficile Infection, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Why this study was terminated

Administrative reasons

Phase: Phase 2
Study type: Interventional
Enrollment: 9
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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).

Conditions studied

Recurrent Clostridium Difficile Infection

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 9 is below the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
a. 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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 9 participants (actual)

Study arms

Experimental
Single dose of PMT
Drug: Penn Microbiome Therapy - 001 · Drug: Penn Microbiome Therapy - 002 · Drug: Penn Microbiome Therapy - 003
Experimental
Two doses of PMT
Administered within 24 hours
Drug: Penn Microbiome Therapy - 001 · Drug: Penn Microbiome Therapy - 002 · Drug: Penn Microbiome Therapy - 003

Interventions

DrugPenn Microbiome Therapy - 001
Fecal Microbiota for Transplant, enema product
Also known as: PMT-001
DrugPenn Microbiome Therapy - 002
Fecal Microbiota for Transplant, suspension product
Also known as: PMT-002
DrugPenn Microbiome Therapy - 003
Fecal Microbiota for Transplant, capsule product
Also known as: PMT-003

What researchers measure

Primary outcomes

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
Time frame: 8 weeks

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

Posted Nov 1, 2023

Participant flow

Participant flow — Overall Study
Milestone	Single Dose of PMT	Two Doses of PMT
Started	5	4
Completed	5	4
Not completed	0	0

Outcome measures

PrimaryNumber 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

Time frame:: 8 weeks
Reported as:: Count of participants · Participants

Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.
Participants	Single Dose of PMT	Two Doses of PMT
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.	1	2

SecondaryAll-cause Mortality at 30-days Following Last FMT

Time frame:: 30 days
Reported as:: Count of participants · Participants

All-cause Mortality at 30-days Following Last FMT
Participants	Single Dose of PMT	Two Doses of PMT
All-cause Mortality at 30-days Following Last FMT	0	0

SecondaryAll-cause Mortality at 60-days Following Last FMT

Time frame:: 60 days
Reported as:: Count of participants · Participants

All-cause Mortality at 60-days Following Last FMT
Participants	Single Dose of PMT	Two Doses of PMT
All-cause Mortality at 60-days Following Last FMT	0	0

SecondaryColectomy or Diverting Ileostomy Within 30 Days After Last FMT

Time frame:: 30 days
Reported as:: Count of participants · Participants

Colectomy or Diverting Ileostomy Within 30 Days After Last FMT
Participants	Single Dose of PMT	Two Doses of PMT
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT	0	0

SecondaryCumulative Days of Hospitalization From Enrollment Until 30 Days After FMT

Time frame:: 30 days
Reported as:: Median · days

Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT
days	Single Dose of PMT	Two Doses of PMT
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT	10 (5 to 16)	1 (1 to 1.5)

SecondaryCumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT

Time frame:: 30 Days
Reported as:: Median · days

Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT
days	Single Dose of PMT	Two Doses of PMT
Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT	0 (0 to 0)	0 (0 to 0)

SecondaryBacteremia From Enrollment Until 30 Days After Last FMT

Time frame:: 30 days
Reported as:: Count of participants · Participants

Bacteremia From Enrollment Until 30 Days After Last FMT
Participants	Single Dose of PMT	Two Doses of PMT
Bacteremia From Enrollment Until 30 Days After Last FMT	1	0

SecondaryHospital Admission Within 60 Days of Discharge From Index Hospitalization

Time frame:: 60 days
Reported as:: Count of participants · Participants

Hospital Admission Within 60 Days of Discharge From Index Hospitalization
Participants	Single Dose of PMT	Two Doses of PMT
Hospital Admission Within 60 Days of Discharge From Index Hospitalization	3	1

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Single Dose of PMT	0/5 (0%)	3/5 (60%)	5/5 (100%)
Two Doses of PMT	0/4 (0%)	3/4 (75%)	4/4 (100%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Single Dose of PMT	Two Doses of PMT
SepsisInfections and infestations	2/5	0/4
Acute kidney injuryRenal and urinary disorders	1/5	1/4
ColitisGastrointestinal disorders	0/5	1/4
DiahrrheaGastrointestinal disorders	0/5	1/4
Gastrointestinal disorders-otherGastrointestinal disorders	0/5	1/4
HypotensionVascular disorders	0/5	1/4
Lung infectionInfections and infestations	0/5	1/4
Peritoneal infectionInfections and infestations	0/5	1/4
Surgical and medical procedures-otherSurgical and medical procedures	0/5	1/4
AnemiaBlood and lymphatic system disorders	1/5	0/4

Most frequent other events

Showing 10 of 53

Most frequent other events
Event	Single Dose of PMT	Two Doses of PMT
DyspneaRespiratory, thoracic and mediastinal disorders	0/5	3/4
DiarrheaGastrointestinal disorders	3/5	2/4
NauseaGastrointestinal disorders	3/5	1/4
Abdominal painGastrointestinal disorders	0/5	2/4
BloatingGastrointestinal disorders	0/5	2/4
HeadacheNervous system disorders	1/5	2/4
Acute kidney injuryRenal and urinary disorders	1/5	2/4
HypertensionVascular disorders	0/5	2/4
HypotensionVascular disorders	1/5	2/4
AscitesGastrointestinal disorders	2/5	1/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Single Dose of PMT	Two Doses of PMT	Total
<=18 years	0	0	0
Between 18 and 65 years	2	3	5
>=65 years	3	1	4

Sex: Female, Male
Sex: Female, Male(Participants)	Single Dose of PMT	Two Doses of PMT	Total
Female	4	3	7
Male	1	1	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Single Dose of PMT	Two Doses of PMT	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	2	5
White	2	1	3
More than one race	0	0	0
Unknown or Not Reported	0	1	1

Region of Enrollment
Region of Enrollment(participants)	Single Dose of PMT	Two Doses of PMT	Total
United States	5	4	9

Study locations

1 site

Hospital of the Univeristy of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jun 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03973697
Lead sponsor: University of Pennsylvania
Responsible party: Sponsor
First posted: Jun 4, 2019
Start date: Jan 13, 2020
Primary completion: Aug 11, 2021
Completion: Dec 31, 2021
Results posted: Nov 1, 2023
Last update: Nov 1, 2023

Study contacts

Ebbing Lautenbach, MD, MPH, MSCE

principal investigator · University of Pennsylvania

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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