Stool Transplants to Treat Refractory Clostridium Difficile Colitis

NCT02127398 | Recruiting Phase 2

• 1 other identifier: Pro00053348
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Keywords

C. difficile colitis; fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Recurrent colitis due to Clostridium difficile

  Patients will be followed 1, 7, 28, and 180 days after the treatment and success will be defined as resolution of C. difficile infection without recurrence within a six-month time period. Patients will be assessed by interview and physical exam. Any patients with suspected persisting/recurring C. difficile colitis will undergo further evaluation with a repeat stool C. difficile toxin assay.

  six months

Secondary Outcomes (6)

• Tolerability of oral fecal microbiota transplantation

  six months

• Safety of oral fecal microbiota transplantation

  six months

• rate of repeat therapy for C. difficile colitis within 6 months of fecal microbiota transplantation.

  six months

• Rate of hospitalization

  six months

• Mortality

  six months

Study Arms (1)

fecal microbiota transplantation

EXPERIMENTAL

fecal microbiota transplantation

Biological: fecal microbiota

Interventions

fecal microbiota BIOLOGICAL

fecal microbiota in capsule form

fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Gary M Cox, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary M Cox, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 30, 2014
• Study Start: April 1, 2016
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

US (1)