Trial Outcomes & Findings for Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection (NCT NCT03973697)
NCT ID: NCT03973697
Last Updated: 2023-11-01
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-11-01
Participant Flow
Participant milestones
| Measure |
Single Dose of PMT
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksClinical 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
Outcome measures
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
All-cause Mortality at 30-days Following Last FMT
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 daysOutcome measures
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
All-cause Mortality at 60-days Following Last FMT
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT
|
10 days
Interval 5.0 to 16.0
|
1 days
Interval 1.0 to 1.5
|
SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
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 0.0
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
Bacteremia From Enrollment Until 30 Days After Last FMT
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 daysOutcome measures
| Measure |
Single Dose of PMT
n=5 Participants
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 Participants
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
Hospital Admission Within 60 Days of Discharge From Index Hospitalization
|
3 Participants
|
1 Participants
|
Adverse Events
Single Dose of PMT
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Two Doses of PMT
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Dose of PMT
n=5 participants at risk
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 participants at risk
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Nervous system disorders
Cognitive disturbance
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diahrrhea
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Enterocolitis
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders-other
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Infections and infestations
Sepsis
|
40.0%
2/5 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures-other
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Single Dose of PMT
n=5 participants at risk
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
Two Doses of PMT
n=4 participants at risk
Administered within 24 hours
Penn Microbiome Therapy - 001: Fecal Microbiota for Transplant, enema product
Penn Microbiome Therapy - 002: Fecal Microbiota for Transplant, suspension product
Penn Microbiome Therapy - 003: Fecal Microbiota for Transplant, capsule product
|
|---|---|---|
|
Investigations
Weight loss
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders-other
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • 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
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • 6 months
|
50.0%
2/4 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
40.0%
2/5 • Number of events 3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Belching
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/5 • 6 months
|
50.0%
2/4 • Number of events 4 • 6 months
|
|
Gastrointestinal disorders
Dehydration
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
3/5 • Number of events 5 • 6 months
|
50.0%
2/4 • Number of events 9 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • 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
|
|
Gastrointestinal disorders
Epistaxis
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
40.0%
2/5 • Number of events 3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
40.0%
2/5 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders-other
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Rectal pain
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
Investigations-Other
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Investigations-other
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
Lipase increased
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
Weight gain
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • 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
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • Number of events 1 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
20.0%
1/5 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Otitis media
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissues disorders-other
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders-other
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
General disorders
Chills
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
General disorders
Fever
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
Malaise
|
0.00%
0/5 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place