Penn Microbiome Therapy for Recurrent Clostridium Diffici... | NCT03973697

NCT03973697

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Administered within 24 hours	Drug: Penn Microbiome Therapy - 001 Drug: Penn Microbiome Therapy - 002 Drug: Penn Microbiome Therapy - 003

Name	Type	Description	Arm Group Labels	Other Names
Penn Microbiome Therapy - 001	Drug	Fecal Microbiota for Transplant, enema product	Single dose of PMT Two doses of PMT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
All-cause Mortality at 30-days Following Last FMT		30 days
All-cause Mortality at 60-days Following Last FMT		60 days
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT

Eligibility Module

Eligibility Criteria

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:

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.

Name	Affiliation	Role
Ebbing Lautenbach, MD, MPH, MSCE	University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the Univeristy of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

Arm/Group Information

ID	Title	Description
FG000	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
FG001	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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	Two Doses of PMT

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Count of Participants

Participants

8 weeks

ID	Title	Description
OG000	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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections