C.Difficile ColitisEGESTANCT02968511
EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota Transplant
A study testing fecal microbiota transplant in people with C.Difficile Colitis, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- C.Difficile Colitis
- What is being tested?
- fecal microbiota transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to 14 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.)
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota
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.
Read the 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.
- Conditions
- C.Difficile Colitis
- Being tested
- fecal microbiota transplant
- Medical subject headings
- Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantBiological
Also called FMT Microbiota Preparation
Fecal microbiota transplant for the treatment of severe, complicated C. difficile infection
| Study group | Role | What they receive |
|---|---|---|
| fecal microbiota transplant | Experimental | 250 mL of fecal transplant material by enema as treatment Receives: Biological: fecal microbiota transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - adverse events
Absence of unexpected related adverse events
Measured: Thirty days after treatment
Secondary outcomes (1)
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
Measured: Thirty days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start15 Sep 2016
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Why it stopped: Lack of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Difficile ColitisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- OpenBiome
- Responsible party
- Principal investigator, David B. Stewart, MD, FACS, FASCRS, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968511
- Sponsor's protocol ID
- STUDY00005388
- Acronym
- EGESTA
- Status last verified
- Nov 2017
- First submitted
- 11 Nov 2016
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota
- ClinicalTrials.gov ID
- NCT02968511
- Acronym / sponsor ID
- EGESTA / STUDY00005388
- Conditions
- C.Difficile Colitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of eligible patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- OpenBiome
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fecal microbiota transplant | Experimental | Biological: fecal microbiota transplant250 mL of fecal transplant material by enema as treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (21 listed)
- 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:
- Individuals who have received FMT at any time before potential study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal microbiota transplantAlso: FMT Microbiota PreparationFecal microbiota transplant for the treatment of severe, complicated C. difficile infection | Biological | fecal microbiota transplant |
Primary outcome
Safety - adverse events
Time frame: Thirty days after treatment
Absence of unexpected related adverse events
1 secondary outcome
Efficacy (Cure of infection, or decrease in severity of infection based on white blood cell count)
Time frame: Thirty days after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fecal microbiota transplant in people with C.Difficile Colitis, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - adverse events (time frame: Thirty days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.