Stool Transplants to Treat Refractory Clostridium Difficile Colitis
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|ClinicalTrials.gov Identifier: NCT02127398|
Recruitment Status : Recruiting
First Posted : April 30, 2014
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Colitis||Biological: fecal microbiota||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation in Refractory Clostridium Difficile Colitis|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: fecal microbiota transplantation
fecal microbiota transplantation
Biological: fecal microbiota
fecal microbiota in capsule form
- Recurrent colitis due to Clostridium difficile [ Time Frame: six months ]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.
- Tolerability of oral fecal microbiota transplantation [ Time Frame: six months ]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.
- Safety of oral fecal microbiota transplantation [ Time Frame: six months ]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.
- rate of repeat therapy for C. difficile colitis within 6 months of fecal microbiota transplantation. [ Time Frame: six months ]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.
- Rate of hospitalization [ Time Frame: six months ]
- Mortality [ Time Frame: six months ]Number of people who die
- Rate of adverse events [ Time Frame: six months ]number of serious AE's occurring within 6 months of transplant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127398
|Contact: Gary M Cox, MDemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Gary M Cox, MD 919-668-3271 firstname.lastname@example.org|
|Principal Investigator: Gary M Cox, MD|
|Principal Investigator:||Gary M Cox, MD||Duke University|