A Phase 2 interventional study of fecal microbiota in Clostridium Difficile Colitis, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
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.
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.
43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.
This study's planned enrollment of 77 is below the median of 100 across 29 interventional studies indexed under Enterocolitis, Pseudomembranous.
Browse Enterocolitis, Pseudomembranous studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
fecal microbiota transplantation
Biological: fecal microbiota
fecal microbiota in capsule form
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.
Time frame: six months
Tolerability of oral fecal microbiota transplantation
We will monitor for side effects during the administration of the fecal microbiota capsules by close observation within the clinic for one hour. All subjects will return 24 hours after administration for repeat examination and for repeat assessment of tolerability using a questionnaire. Symptoms that will be specifically monitored include the patient's subjective measure of nausea, vomiting, abdominal cramping/pain, belching, diarrhea, constipation, and changes in the quantity or quality of stool.
Time frame: six months
Safety of oral fecal microbiota transplantation
The main safety concern is for the transmission of infection from the donor to the recipient. At each follow-up visit (1, 7, 28, and 180 days after treatment) subjects will be assessed for any signs or symptoms of infection by history and physical exam. Some of the specific infections that will be considered will be infectious colitis, infection due to Helicobacter pylori, viral hepatitis, and HIV infection. Patients with signs or symptoms of a suspected infection will undergo appropriate workup with blood and/or stool studies.
Time frame: six months
rate of repeat therapy for C. difficile colitis within 6 months of fecal microbiota transplantation.
All subjects will return for evaluation with a comprehensive history and physical exam 180 days after fecal microbiota transplantation, and patients will be asked if they have required any form of therapy for C. difficile colitis in the interim.
Time frame: six months
Rate of hospitalization
Time frame: six months
Mortality
Number of people who die
Time frame: six months
Rate of adverse events
number of serious AE's occurring within 6 months of transplant
Time frame: six months
The record gives a start of Apr 2016, a primary completion of May 2027 and a completion of May 2027. It does not say whether these dates are actual or estimated.
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