WithdrawnNot Applicable

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

Stopped: Lack of eligible patients

United States0Started 2016-09-15

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, regardles…

What they're measuring

Safety - adverse events

Timeframe: Thirty days after treatment

Trial details

NCT IDNCT02968511

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-14