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EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota Transplant (EGESTA)

Primary Purpose

C.Difficile Colitis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fecal microbiota transplant
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for C.Difficile Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults between 18 years of age and 75 years of age.
  • Have CDI defined as clinical symptoms of CDI (diarrhea with or without abdominal pain/abdominal distention) with a confirmatory nucleic acid amplification test (NAAT) positive for CDI.

  • Have severe/complicated disease as defined by ACG guidelines(appendix 1), with any of the following attributable to CDI:

    • Admission to intensive care unit for CDI
    • Hypotension (systolic blood pressure < 90 mmHg) with or without required use of vasopressors
    • Fever ≥ 38.5 ° C
    • Ileus (as defined by the absence of intestinal function for at least 24 hours and/or radiographic evidence of pathologically dilated small intestine without evidence of a mechanical obstruction) or significant abdominal distention
    • Mental status changes
    • WBC ≥ 35,000 cells / mm 3 or < 2,000 cells / mm 3
    • Serum lactate levels >2.2 mmol / l
    • End organ failure (mechanical ventilation,renal failure as defined by a rise in creatinine of >1.5 mg/dL either above the upper limit of normal for creatinine, or > 1.5 mg/dL from premorbid levels if that information is known, acute hepatic dysfunction as defined by an increase in AST or ALT to twice the upper limit of normal, etc.)

Exclusion Criteria:

  • Pregnant or lactating women
  • Prisoners
  • Patients under the age of 18 or over the age of 76 years of age

  • Patients who are immunocompromised including but not limited to:

    • Have HIV infection historically reported, regardless of CD4 count
    • AIDS as defined by either an AIDS-defining diagnosis (appendix 2) or a CD4 count <200/mm3,
    • Inherited or primary immune disorders,
    • Received chemotherapy within the previous 90 days, or
    • Current or recent treatment with any immunosuppressant medications in the past 90 days
  • Individuals who have received FMT at any time before potential study enrollment
  • Patients who do not have a stool test confirming C. difficile infection
  • Patients who have a severe anaphylactic response to food
  • Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
  • Patients who have colorectal cancer
  • Diagnosis of Irritable Bowel Disease or Irritable Bowel Syndrome
  • Any other condition for which the Principal Investigator thinks the treatment may pose a health risk
  • Anticipated or predicted death within the time period of follow-up for reasons unrelated to CDI
  • An APACHE II score >29 at the time of evaluation for inclusion in the study protocol (Appendix 4.0)
  • Mandatory ongoing antibiotic use for non-CDI infection
  • Patients unable to provide informed consent or who do not have a legally authorized representative for consent
  • Patients unable to comply with requirements of this study protocol

Sites / Locations

  • David Stewart

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fecal microbiota transplant

Arm Description

250 mL of fecal transplant material by enema as treatment

Outcomes

Primary Outcome Measures

Safety - adverse events
Absence of unexpected related adverse events

Secondary Outcome Measures

Efficacy (Cure of infection, or decrease in severity of infection based on white blood cell count)
Cure of infection, or decrease in severity of infection based on white blood cell count

Full Information

First Posted
November 11, 2016
Last Updated
November 22, 2017
Sponsor
Milton S. Hershey Medical Center
Collaborators
OpenBiome
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1. Study Identification

Unique Protocol Identification Number
NCT02968511
Brief Title
EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota Transplant
Acronym
EGESTA
Official Title
EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of eligible patients
Study Start Date
September 15, 2016 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
OpenBiome

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C. difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota transplant (FMT) can improve scCDI, with "improve" defined as either decreasing the severity of CDI, or by resolving the infection altogether. Third, the study seeks to further study the mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy donors. The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.
Detailed Description
The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C. difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota transplant (FMT) can improve scCDI, with "improve" defined as either decreasing the severity of CDI, or by resolving the infection altogether. Third, the study seeks to further study the mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy donors. The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery. The standard of care treatment for scCDI is conventional antibiotics with either parenteral/oral metronidazole, and/or vancomycin provided in the form of oral and/or retention enemas. The reliability of these conventional antibiotics in the setting of scCDI is very unpredictable, and patients with CDI of this severity have a mortality rate that in some series is greater than 50%. It is against the mediocre historical record of these antibiotics that FMT would be tested in this highly moribund patient population. FMT would not be provided to patients with scCDI off protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C.Difficile Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fecal microbiota transplant
Arm Type
Experimental
Arm Description
250 mL of fecal transplant material by enema as treatment
Intervention Type
Biological
Intervention Name(s)
fecal microbiota transplant
Other Intervention Name(s)
FMT Microbiota Preparation
Intervention Description
Fecal microbiota transplant for the treatment of severe, complicated C. difficile infection
Primary Outcome Measure Information:
Title
Safety - adverse events
Description
Absence of unexpected related adverse events
Time Frame
Thirty days after treatment
Secondary Outcome Measure Information:
Title
Efficacy (Cure of infection, or decrease in severity of infection based on white blood cell count)
Description
Cure of infection, or decrease in severity of infection based on white blood cell count
Time Frame
Thirty days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults between 18 years of age and 75 years of age. Have CDI defined as clinical symptoms of CDI (diarrhea with or without abdominal pain/abdominal distention) with a confirmatory nucleic acid amplification test (NAAT) positive for CDI. Have severe/complicated disease as defined by ACG guidelines(appendix 1), with any of the following attributable to CDI: Admission to intensive care unit for CDI Hypotension (systolic blood pressure < 90 mmHg) with or without required use of vasopressors Fever ≥ 38.5 ° C Ileus (as defined by the absence of intestinal function for at least 24 hours and/or radiographic evidence of pathologically dilated small intestine without evidence of a mechanical obstruction) or significant abdominal distention Mental status changes WBC ≥ 35,000 cells / mm 3 or < 2,000 cells / mm 3 Serum lactate levels >2.2 mmol / l End organ failure (mechanical ventilation,renal failure as defined by a rise in creatinine of >1.5 mg/dL either above the upper limit of normal for creatinine, or > 1.5 mg/dL from premorbid levels if that information is known, acute hepatic dysfunction as defined by an increase in AST or ALT to twice the upper limit of normal, etc.) Exclusion Criteria: Pregnant or lactating women Prisoners Patients under the age of 18 or over the age of 76 years of age Patients who are immunocompromised including but not limited to: Have HIV infection historically reported, regardless of CD4 count AIDS as defined by either an AIDS-defining diagnosis (appendix 2) or a CD4 count <200/mm3, Inherited or primary immune disorders, Received chemotherapy within the previous 90 days, or Current or recent treatment with any immunosuppressant medications in the past 90 days Individuals who have received FMT at any time before potential study enrollment Patients who do not have a stool test confirming C. difficile infection Patients who have a severe anaphylactic response to food Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS) Patients who have colorectal cancer Diagnosis of Irritable Bowel Disease or Irritable Bowel Syndrome Any other condition for which the Principal Investigator thinks the treatment may pose a health risk Anticipated or predicted death within the time period of follow-up for reasons unrelated to CDI An APACHE II score >29 at the time of evaluation for inclusion in the study protocol (Appendix 4.0) Mandatory ongoing antibiotic use for non-CDI infection Patients unable to provide informed consent or who do not have a legally authorized representative for consent Patients unable to comply with requirements of this study protocol
Facility Information:
Facility Name
David Stewart
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17078
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota Transplant

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