Investigating four different treatment of MTC or FMT
The purpose of this research study is to compare two different treatments for patients with recurrent Clostridiodies difficile infections: MTC01 vs fecal microbiota transplantation (FMT). FMT is the transfer of bacteria from a healthy donor's colon to a recipient's colon. To do this, stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy. This treatment is now considered standard medical care for recurrent Clostridioides difficile infections. One FMT dose contains the entire collection of microbes in a healthy donor and is made up of billions of microbes. Each dose of FMT is different from the next and it is unknown exactly what microbes are present in each dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Slurry to be administered via colonoscopy
Stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy
Icahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGNumber of treatment-related serious adverse events (SAE) as assessed by NIH grading
Number of serious adverse events per NIH grading indications. Grade 1-5, where grade 3-5 are considered severe. 1. Mild 2. Moderate 3. Severe 4. Life threatening 5. Death Serious Adverse Event (SAE): Any adverse event that: * Results in death * Is life threatening, or places the participant at immediate risk of death from the event as it occurred * Requires or prolongs hospitalization * Causes persistent or significant disability or incapacity * Results in congenital anomalies or birth defects * Is another condition which investigators judge to represent significant hazards
Time frame: up to 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0, grade 1-2, where higher grades indicate higher levels of impairment. 1. Mild 2. Moderate 3. Severe 4. Life threatening 5. Death
Time frame: up to 24 weeks
Percent of patients who develop Clostridioides difficile (C difficile)
Recurrence of Clostridioides difficile (C difficile) within 8 weeks of receiving treatment. The stool C difficile toxin test detects harmful substances produced by the C difficile bacterium . This infection is a common cause of diarrhea after antibiotic use. Abnormal results mean that toxins produced by C difficile are seen in the stool and are causing diarrhea.
Time frame: within 8 weeks
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