Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Description

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.

Conditions

Clostridium Difficile Colitis

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Study Overview

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Study Details

Study overview

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.

Fecal Microbiota Transplantation in Refractory Clostridium Difficile Colitis

Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Condition
Clostridium Difficile Colitis
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Gary M Cox, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2026-05