Recruiting
Phase 2

Stool Transplants

Sponsor:

Duke University

Code:

NCT02127398

Conditions

Clostridium Difficile Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

fecal microbiota

Study Details

Brief 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.

Conditions

Clostridium Difficile Colitis

Study ID

NCT02127398

Start date

Apr, 2016

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

77 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: fecal microbiota transplantation

fecal microbiota transplantation

Interventions

fecal microbiota

fecal microbiota in capsule form

Primary outcome measure

  • Recurrent colitis due to Clostridium difficile [ Time Frame: six months ]

Central Contacts and Locations

Central contacts

Gary M Cox, MD

919-668-3271gary.cox@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Gary M Cox, MD

919-668-3271gary.cox@duke.edu

Principal Investigator:

Gary M Cox, MD

More Information

Sponsor

Duke University

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • C. difficile colitis
  • fecal microbiota transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.