Clinical trial NCT02127398: Stool Transplants to Treat Refractory Clostridium Difficile Colitis
Official title: Fecal Microbiota Transplantation in Refractory Clostridium Difficile Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Clostridium Difficile Colitis
Keywords: C. difficile colitis
fecal microbiota transplantation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Recurrent colitis due to Clostridium difficile results from disruption of the normal gut flora, and is very difficult to treat. It is now clear that restoration of the normal gut flora is the most effective way to treat recurrent C. difficile colitis. Restoration of the normal gut flora is best done by transplanting stool from a healthy donor, and this is accepted as a superior therapeutic modality for recurrent C. difficile colitis. This fecal microbiota transplantation can be done with direct instillation of the donor stool into the GI tract via a naso-duodenal tube or colonoscope. Recently, a non-invasive method of stool transplantation has been developed where the donor stool is encapsulated and administered in pill form. The investigators would like to use fecal microbiota transplantation with encapsulated stool as a non-invasive therapy for patients with recurrent C. difficile colitis. To qualify, patients must have a history of, at least, 3 episodes of C difficile colitis within the past year or, at least, 2 episodes of C difficile colitis that resulted in hospitalization. Stool samples will be obtained from healthy volunteers who have been screened for infections that can be transmitted via stool, and the investigators will prepare capsules containing processed stool for administration during a single outpatient clinic visit. Patients will be followed closely after administration of the fecal transplant with serial clinic visits, and the primary endpoint will be prevention of any further episodes of C. difficile colitis in the six month period following transplantation. The investigators will also obtain and store stool samples from patients before and after fecal microbiota transplantation for possible future microbiome analyses. The obvious safety concern is the transmission of an infection from the donor. All donors will be carefully screened for high-risk exposures and will undergo testing of both blood and stool to ensure that they are free of infections due to HIV, acute hepatitis A, acute/chronic hepatitis B, hepatitis C, giardiasis, cryptosporidiosis, and Helicobacter pylori.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent colitis due to Clostridium difficile
timeFrame: six months
Secondary outcomes:
measure: Tolerability of oral fecal microbiota transplantation
timeFrame: six months
measure: Safety of oral fecal microbiota transplantation
timeFrame: six months
measure: rate of repeat therapy for C. difficile colitis within 6 months of fecal microbiota transplantation.
timeFrame: six months
measure: Rate of hospitalization
timeFrame: six months
measure: Mortality
timeFrame: six months
measure: Rate of adverse events
timeFrame: six months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Gary M Cox, MD
role: PRINCIPAL_INVESTIGATOR
References: