Name (Synonyms) | Correlation | |
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drug920 | Double-Blind Placebo Wiki | 1.00 |
drug1098 | Fecal Microbiota Therapy (FMT) Wiki | 1.00 |
drug919 | Double-Blind NT-I7 Wiki | 1.00 |
drug2122 | Placebo Wiki | 0.05 |
Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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There is one clinical trial.
The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.
Description: The primary outcome is recurrent CDI (definite or probable) or death within 56 days of randomization. Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days Other clinical symptoms including ileus, toxic mega colon, or colectomy PLUS Laboratory confirmation of C. difficile from a stool specimen. Probable recurrence is defined as the same clinical manifestations as above, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative result, or uninterpretable result).
Measure: Recurrent CDI (definite or probable) or death Time: Within 56 days of randomizationDescription: The incidence of recurrent CDI (definite or possible) or death within 6 months of randomization.
Measure: Recurrent CDI (definite or possible), or death Time: Within 6 months of randomizationDescription: The investigators will use a brief assessment of both overall and gastrointestinal health status, using a previously validated instrument.
Measure: Quality of Life Time: 56 days from randomizationDescription: The number of CDI recurrences within 6 months for a patient is the count of separate CDI recurrences from randomization to 6 months after randomization.
Measure: Number of CDI recurrences Time: Within 6 months of randomizationDescription: This is similar to probable recurrent CDI, but includes only episodes of diarrhea that test negative for C. difficile by EIA toxin test and PCR, not episodes that are not tested or are uninterpretable.
Measure: Diarrhea that is negative for C. difficile by EIA toxin test and PCR Time: Within 56 days of randomizationDescription: An assessment for non-diarrheal manifestations of CDI such as abdominal pain, urgency, and fecal incontinence will be performed.
Measure: Multiple related symptoms Time: Within 6 months of randomizationDescription: The incidence of definite recurrent CDI within 56 days of randomization. Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days Other clinical symptoms including ileus, toxic mega colon, or colectomy PLUS Laboratory confirmation of C. difficile from a stool specimen.
Measure: Definite recurrent CDI Time: Within 56 days of randomizationDescription: The incidence of probable recurrent CDI within 56 days of randomization. Possible recurrence is defined as the same clinical manifestations as definite recurrent CDI, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative result, or uninterpretable result).
Measure: Possible recurrent CDI Time: Within 56 days of randomizationDescription: The incidence of death within 56 days of randomization.
Measure: Death Time: Within 56 days of randomizationDescription: This is similar to possible recurrent CDI, but includes only episodes of diarrhea that test negative for C. difficile by EIA toxin test, not episodes that are not tested or are uninterpretable.
Measure: Diarrhea that is negative for C. difficile by EIA toxin testing but positive by PCR Time: Within 56 days of randomizationDescription: Safety outcomes to be collected include: Serious adverse events, with a focus on SAEs involving hospitalization (new or prolonged), and all-cause mortality Adverse events which may be related to FMT treatment. This includes adverse events which Site Investigators consider related/possibly related to the study treatment and all adverse events which occur within 14 days of study treatment (since an aggregate analysis of events temporally linked to treatment could show a causal relationship when compared to placebo) Infectious transmissions which are plausibly linked to FMT treatment. Development of new conditions theoretically linked to alterations in gut microbiota.
Measure: Adverse and Serious Adverse Events Time: Within 6 months of randomization