Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT02127398

Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Led by Duke University · Updated on 2025-08-13

77

Participants Needed

1

Research Sites

526 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old
  • History of three or more episodes of Clostridium difficile colitis within the past 12 months
Not Eligible

You will not qualify if you...

  • Absolute neutrophil count less than 500 cells per mm3
  • Active infection at other sites (excluding Clostridium difficile) requiring ongoing antibacterial therapy
  • Current or planned cytotoxic chemotherapy within 14 days before transplantation
  • Life expectancy under 180 days
  • Diagnosis of inflammatory bowel disease such as Crohn's disease or ulcerative colitis
  • Inability to swallow capsules
  • Presence of 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 evidence of proper treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

G

Gary M Cox, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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