Trial Outcomes & Findings for Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI) (NCT NCT03970200)
NCT ID: NCT03970200
Last Updated: 2023-10-30
Results Overview
The outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 72 hours: * If radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved * Ileus/megacolon either noted as resolved by any provider documentation or not noted * White Blood Cells (WBC) \<15,000 cells/uL * Serum creatinine decreased, unchanged, or increased by ≤0.2 mg/dL over 72 hours (if not receiving continuous renal replacement therapy (CRRT) or hemodialysis (HD)) * Lactate ≤2.2 mmol/L (if measured by clinical care team) * No vasopressors used (including epinephrine, norepinephrine, phenylephrine, or vasopressin) * Temperature \<38.5 °C and ≥35.6°C * \< 8 bowel movements per day and \< 600 mL unformed stool (if volume recorded) * Meeting fewer than 3 systemic inflammatory response syndrome (SIRS) criteria
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
3 Days
Results posted on
2023-10-30
Participant Flow
Participant milestones
| Measure |
No Investigational Product
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
Participants who receive the antibiotics usually prescribed for C diff infection, along with Penn Microbiome Therapy (PMT) that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
6
|
|
Overall Study
COMPLETED
|
3
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
No Investigational Product
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
Participants who receive the antibiotics usually prescribed for C diff infection, along with Penn Microbiome Therapy (PMT) that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
1
|
|
Overall Study
Subject re-enrolled into Upper GI
|
0
|
0
|
1
|
Baseline Characteristics
Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)
Baseline characteristics by cohort
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 DaysThe outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 72 hours: * If radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved * Ileus/megacolon either noted as resolved by any provider documentation or not noted * White Blood Cells (WBC) \<15,000 cells/uL * Serum creatinine decreased, unchanged, or increased by ≤0.2 mg/dL over 72 hours (if not receiving continuous renal replacement therapy (CRRT) or hemodialysis (HD)) * Lactate ≤2.2 mmol/L (if measured by clinical care team) * No vasopressors used (including epinephrine, norepinephrine, phenylephrine, or vasopressin) * Temperature \<38.5 °C and ≥35.6°C * \< 8 bowel movements per day and \< 600 mL unformed stool (if volume recorded) * Meeting fewer than 3 systemic inflammatory response syndrome (SIRS) criteria
Outcome measures
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products.
|
4 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 DaysNumber of deaths within 30 days of the last FMT
Outcome measures
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
All-cause Mortality at 30 Days Following Last Fecal Microbiota Transplantation (FMT)
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 60 DaysNumber of deaths within 60 days of the last FMT
Outcome measures
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
All-cause Mortality at 60-days Following Last FMT
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT
|
13 days
Interval 6.0 to 16.0
|
8 days
Interval 4.0 to 13.5
|
14 days
Interval 4.0 to 16.0
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 4.5
|
0 days
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Bacteremia From Enrollment Until 30 Days After Last FMT
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 DaysOutcome measures
| Measure |
No Investigational Product
n=5 Participants
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=2 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 Participants
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Repeat Hospital Admission Within 60 Days of Discharge From Index Hospitalization
|
2 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
No Investigational Product
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Upper Gastrointestinal Fecal Microbiota Transplantation
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Lower Gastrointestinal Fecal Microbiota Transplantation
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
No Investigational Product
n=5 participants at risk
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 participants at risk
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 participants at risk
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Cardiac disorders
Heart failure
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 2 • 6 months
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
General disorders
Death NOS
|
40.0%
2/5 • Number of events 2 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Edema limbs
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
General disorders
Hypothermia
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 2 • 6 months
|
0.00%
0/6 • 6 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Nervous system disorders
Ischemia cerebrovascular
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 2 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
Other adverse events
| Measure |
No Investigational Product
n=5 participants at risk
Participants who receive the antibiotics usually prescribed for C diff infection.
Antibiotics: Standard of care antibiotics
|
Upper Gastrointestinal Fecal Microbiota Transplantation
n=4 participants at risk
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
Antibiotics: Standard of care antibiotics
|
Lower Gastrointestinal Fecal Microbiota Transplantation
n=6 participants at risk
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Antibiotics: Standard of care antibiotics
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
40.0%
2/5 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
50.0%
3/6 • Number of events 3 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Cardiac disorders
Heart failure
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
33.3%
2/6 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2 • 6 months
|
50.0%
2/4 • Number of events 5 • 6 months
|
50.0%
3/6 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
33.3%
2/6 • Number of events 4 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Number of events 1 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
General disorders
Hypothermia
|
20.0%
1/5 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
General disorders
Malaise
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Infections and infestations
Infections and infestations-Other
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 4 • 6 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
33.3%
2/6 • Number of events 2 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
INR increased
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Lipase increased
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Investigations
Weight gain
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Investigations
Weight loss
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
16.7%
1/6 • Number of events 3 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
33.3%
2/6 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
33.3%
2/6 • Number of events 2 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Other
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Nervous system disorders
Lethargy
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
33.3%
2/6 • Number of events 2 • 6 months
|
|
Reproductive system and breast disorders
Genital edema
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
33.3%
2/6 • Number of events 2 • 6 months
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/6 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place