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Report for D003015: Clostridium Infections NIH

(Synonyms: Clostridium In, Clostridium Infectio, Clostridium Infections)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug829 Eicosapentaenoic acid gastro-resistant capsules Wiki 1.00
drug934 Fecal Microbiota Therapy (FMT) Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 CSP #2004 - Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)

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.

NCT03005379 Clostridium Difficile Infection Drug: Fecal Microbiota Therapy (FMT) Drug: Placebo
MeSH:Clostridium Infections

Primary Outcomes

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 randomization

Secondary Outcomes

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: The incidence of death within 56 days of randomization.

Measure: Death

Time: Within 56 days of randomization

Description: 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 randomization

Other Outcomes

Description: 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


HPO Nodes