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

NCT02968511 | Withdrawn DMC

• 1 other identifier: STUDY00005388
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

C.Difficile Colitis

Outcome Measures

Primary Outcomes (1)

• Safety - adverse events

  Absence of unexpected related adverse events

  Thirty days after treatment

Secondary Outcomes (1)

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

  Thirty days after treatment

Study Arms (1)

fecal microbiota transplant

EXPERIMENTAL

250 mL of fecal transplant material by enema as treatment

Biological: fecal microbiota transplant

Interventions

fecal microbiota transplant BIOLOGICAL

Fecal microbiota transplant for the treatment of severe, complicated C. difficile infection

Also known as: FMT Microbiota Preparation

fecal microbiota transplant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• OpenBiome: collaborator

Study Sites (1)

David Stewart

Hershey, Pennsylvania, 17078, United States

Location

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surger

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 18, 2016
• Study Start: September 15, 2016
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: November 27, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)