Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile A… (NCT03548051) | Clinical Trial Compass
TerminatedPhase 1/2
Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Stopped: Low enrollment
United States10 participantsStarted 2019-01-11
Plain-language summary
Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with recurrent Clostridium difficile Associated Disease (CDAD). 162 male or female subjects will be enrolled in the study. Enrolled subjects will be randomized at each site to receive either FMT by enema or placebo by enema in a 2:1 ratio. Study duration is 3 years, subject participation duration is approximately 1 year. The primary study objectives are: 1) to evaluate the safety of FMT(s) delivered by enema vs. placebo delivered by enema and 2) to determine efficacy of FMT delivered by enema vs. placebo delivered by enema.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Providing permission to access the medical record.
✓. Male or non-pregnant female 18 years or older at the time of enrollment.
✓. Able to provide signed and dated informed consent.
✓. = / \> 2 episodes of Clostridium difficile Associated Disease (CDAD) in the past 12 months, including the last episode if present at screening\*.
✓. Completed treatment course of at least 10 days of oral vancomycin, oral/IV metronidazole, or oral fidaxomicin for the most recent episode prior to enrollment.
✓. Deemed likely to survive for 1 year after enrollment.
✓. Women of childbearing potential\* in sexual relationships with men must use an acceptable method of contraception\*\* from 30 days prior to enrollment until 4 weeks after completing study treatment.
Exclusion criteria
✕
What they're measuring
1
Number of Participants With a New Onset of Related Chronic Medical Condition After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)
Timeframe: Day 1 through Day 365
2
Number of Participants With a Serious Adverse Event (SAE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)
Timeframe: Day 1 through Day 365
3
Number of Participants With an Adverse Event (AE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)
Timeframe: Day 1 through Day 30
4
Number of Participants With Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI), After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)
Timeframe: Day 1 through Day 365
5
Proportion of Participants With Clinical Response (Defined as no Recurrence of Clostridium Difficile-Associated Diarrhea (CDAD))
Timeframe: Day 1 through Day 30
Trial details
NCT IDNCT03548051
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Previous fecal microbiota transplantation (FMT) within the previous 12 months prior to study enrollment.
✕. Any heart, lung, pancreas, or intestinal transplant recipient or any HIV positive transplant recipient.\* \*not excluded from the trial are subjects who are kidney, liver, or liver/kidney transplant recipients AND are more than 6 months from transplantation AND have not had a rejection episode in the past 6 months AND have been stable on immunosuppressive regimen for the past 6 months (any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, will not be considered a deviation of this criterion)
✕. Requiring antibiotics in the past 2 weeks prior to receiving the enema for a condition other than CDAD or scheduled to be used in the upcoming 2 weeks.
✕. Unable to tolerate enema for any reason.
✕. Any GI cancer in the past 6 months or any actively treated malignancy.\*,\*\* \*Not excluded from the trial are subjects with actively treated basal and squamous cell cancers without any systemic treatment.
✕. Patients with a history of severe anaphylactic food allergy.