NCT02968511|WithdrawnDMC
Study Stopped
Lack of eligible patients
EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota Transplant
EGESTA
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Sponsor study identifier
interventional
0
1 country
1
Study Start
September 15, 2016
Actual (reported)Primary Completion
November 14, 2017
Actual (reported)Study Completion
November 14, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 14, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2016
Actual (reported)November 11, 2016
Actual (reported)November 18, 2016
Actual (reported)November 14, 2017
Actual (reported)November 14, 2017
Actual (reported)Safety - adverse events
Absence of unexpected related adverse events
Thirty days after treatment
Efficacy (Cure of infection, or decrease in severity of infection based on white blood cell count)
Thirty days after treatment
250 mL of fecal transplant material by enema as treatment
Fecal microbiota transplant for the treatment of severe, complicated C. difficile infection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
David Stewart
Hershey, Pennsylvania, 17078, United States
0 participants (actual enrollment reported by the registry).
First Submitted
November 11, 2016
First Posted
November 18, 2016
Study Start
September 15, 2016
Actual (reported)Fecal Microbiota Transplant
Contact the study team to confirm eligibility.
Primary Completion
November 14, 2017
Actual (reported)Study Completion
November 14, 2017
Actual (reported)Last Updated
November 27, 2017
Record last verified: 2017-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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