Stool Transplants to Treat Refractory Clostridium Difficile Colitis

  • STATUS
    Recruiting
  • End date
    May 27, 2023
  • participants needed
    10
  • sponsor
    Duke University
Updated on 27 September 2021
microbiota
clostridium difficile

Summary

It has been shown that restoration of the normal makeup of the bowel bacterial population is the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration of the normal bowel bacterial population is best done by transplanting stool from a healthy donor. The investigators wish to transplant stool from healthy donors to treat recurrent C. difficile colitis by incorporating the stool into capsules that are administered by the oral route.

Description

Recurrent colitis due to Clostridium difficile results from disruption of the normal gut flora, and is very difficult to treat. It is now clear that restoration of the normal gut flora is the most effective way to treat recurrent C. difficile colitis. Restoration of the normal gut flora is best done by transplanting stool from a healthy donor, and this is accepted as a superior therapeutic modality for recurrent C. difficile colitis. This fecal microbiota transplantation can be done with direct instillation of the donor stool into the GI tract via a naso-duodenal tube or colonoscope. Recently, a non-invasive method of stool transplantation has been developed where the donor stool is encapsulated and administered in pill form. The investigators would like to use fecal microbiota transplantation with encapsulated stool as a non-invasive therapy for patients with recurrent C. difficile colitis. To qualify, patients must have a history of, at least, 3 episodes of C difficile colitis within the past year or, at least, 2 episodes of C difficile colitis that resulted in hospitalization. Stool samples will be obtained from healthy volunteers who have been screened for infections that can be transmitted via stool, and the investigators will prepare capsules containing processed stool for administration during a single outpatient clinic visit. Patients will be followed closely after administration of the fecal transplant with serial clinic visits, and the primary endpoint will be prevention of any further episodes of C. difficile colitis in the six month period following transplantation. The investigators will also obtain and store stool samples from patients before and after fecal microbiota transplantation for possible future microbiome analyses. The obvious safety concern is the transmission of an infection from the donor. All donors will be carefully screened for high-risk exposures and will undergo testing of both blood and stool to ensure that they are free of infections due to HIV, acute hepatitis A, acute/chronic hepatitis B, hepatitis C, giardiasis, cryptosporidiosis, and Helicobacter pylori.

Details
Condition Clostridium Difficile Colitis
Treatment Fecal microbiota
Clinical Study IdentifierNCT02127398
SponsorDuke University
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Study entry is open to adults (>18 years old) who have had three of more episodes of Clostridium difficile colitis within the previous 12 months

Exclusion Criteria

Absolute neutrophil count < 500 cells/mm3
Active infection at other sites (excluding Clostridium difficile) requiring ongoing antibacterial therapy (antiviral or antifungal therapy is acceptable)
Current or planned cytotoxic chemotherapy within 14 days of the potential fecal transplantation date
Life expectancy <180 days
Diagnosis of inflammatory bowel disease (e.g. Crohn's or ulcerative colitis)
Inability to swallow capsules
Indwelling nasogastric, orogastric, gastrostomy, or jejunostomy tube
History of partial or total gastrectomy
Short gut syndrome requiring total parenteral nutrition
Pregnancy
Documented intestinal parasite infection without documentation of appropriate treatment
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