RECRUITING

Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Fecal Microbiota Transplantation in Refractory Clostridium Difficile Colitis

Quick Facts

Study Start:2016-04
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02127398

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * Absolute neutrophil count \< 500 cells/mm3
  2. * Active infection at other sites (excluding Clostridium difficile) requiring ongoing antibacterial therapy (antiviral or antifungal therapy is acceptable)
  3. * Current or planned cytotoxic chemotherapy within 14 days of the potential fecal transplantation date
  4. * Life expectancy \<180 days
  5. * Diagnosis of inflammatory bowel disease (e.g. Crohn's or ulcerative colitis)
  6. * Inability to swallow capsules
  7. * Indwelling nasogastric, orogastric, gastrostomy, or jejunostomy tube
  8. * History of partial or total gastrectomy
  9. * Short gut syndrome requiring total parenteral nutrition
  10. * Pregnancy
  11. * Documented intestinal parasite infection without documentation of appropriate treatment

Contacts and Locations

Study Contact

Gary M Cox, MD
CONTACT
919-668-3271
gary.cox@duke.edu

Principal Investigator

Gary M Cox, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Duke University

  • Gary M Cox, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04
Study Completion Date2026-05

Study Record Updates

Study Start Date2016-04
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • C. difficile colitis
  • fecal microbiota transplantation

Additional Relevant MeSH Terms

  • Clostridium Difficile Colitis