Clostridium Difficile Infection
Conditions
Keywords
FMT, recurrent c. difficile, infectious disease, intestine, clinical trial, gastrointestinal, prevention, randomized, diarrhea, fecal microbiota therapy
Brief summary
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.
Detailed description
Clostridium difficile infection (CDI) is one of the most common nosocomial infections and is increasingly seen in non-hospitalized patients. Although more than 90% of patients have symptom resolution with a course of standard antimicrobial therapy, subsequent recurrence rates range from 15-30% (after the first CDI episode) to 40-50% (after the second and subsequent episodes). Fecal microbiota transplantation (FMT) has shown promise as an adjunct to standard antimicrobial therapy, reducing recurrence among FMT recipients to 15%. The primary study goal is to assess the efficacy of FMT for the prevention of subsequent recurrent CDI, when administered after successful treatment of recurrent CDI with standard antimicrobial therapy. Secondary goals are to evaluate, the efficacy of FMT in terms of CDI severity, duration, the safety of FMT, and in the event of a positive study result, establish a mechanism for providing FMT within the VA system. This study will enroll 390 participants. Participants will be randomized (1:1 ratio) to FMT or placebo, stratified by number of prior recurrent CDI episodes (1 versus \>1). They will be assessed for symptoms of CDI, other study outcomes and any treatment-related adverse events at 2, 14, 28, 42, and 56 days, and month 3, 4, 5 and 6 after administration of the study treatment. The primary outcome is recurrent CDI (definite or possible) 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, not explained by another diagnosis; Other clinical symptoms including ileus, toxic megacolon, or colectomy; plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test. Possible recurrence is defined as the same clinical manifestations as above, but without laboratory confirmation of C. difficile (stool test not sent, negative EIA toxin test result, or uninterpretable result).
Interventions
DRUGFecal Microbiota Therapy (FMT)
Oral capsule-delivered FMT
DRUGPlacebo
Oral capsule-delivered placebo
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. One or more episodes recurrent CDI (defined as \> 3 loose/watery stools/24h for 2 consecutive days with CDI treatment, and not explained by another diagnosis plus laboratory confirmation of C. difficile; or ileus, or toxic megacolon plus laboratory confirmation of C. difficile, occurring within 90 days of a prior CDI episode with similar symptoms and laboratory confirmation) 2. Resolution or improvement of symptoms from most recent CDI episode, defined as no longer meeting the clinical definition for CDI for a 48 hour period during treatment, including not meeting the definition again after an initial improvement 3. Within the enrollment window: 2 days after completion of antimicrobial therapy for CDI (to allow for a washout period) to 14 days after completion of therapy or 30 days after the onset of CDI whichever is later. 4. Age 18 years 5. Enrolled in a Veterans Health Administration (VHA) facility 6. Able and willing to provide informed consent
Exclusion criteria
1. Unlikely to swallow capsules 2. Pregnancy, planning to be pregnant, or breastfeeding 3. Receipt of cytotoxic chemotherapy, intravenous or subcutaneous immune globulin, or confirmed neutropenia (absolute neutrophil count of \< 1,000 cells/ L) within the past 3 months 4. Inflammatory bowel disease or other chronic diarrheal disease/fecal incontinence predating CDI 5. Ongoing antibiotic use other than those for the current episode of CDI 6. Prior FMT 7. Life expectancy of \< 8 weeks 8. Anaphylactic food allergy 9. Active enrollment in another research study on antibiotics, probiotics, or FMT without investigators approval 10. Presence of an ileostomy or colostomy 11. HIV with Clusters of Differentiation 4 (CD4) cell count \< 200 cells/µL in prior 3 months 12. Decompensated cirrhosis 13. Bone marrow/peripheral blood stem cell transplant in the past year 14. Unlikely to follow study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death | Within 56 days of randomization | The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life at 56 Day | 56 days from randomization | The investigators will use a brief assessment of both overall and gastrointestinal health status, a previously validated instrument called Gastrointestinal Quality of Life Index (GIQLI). GIQLI takes value between 0 and 144, with higher score associated with better quality of life. |
| Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Within 6 months of randomization | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. |
| Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR) | Within 56 days of randomization | This is similar to a possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test and PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. |
| Occurrence of Abdominal Pain Among All Possible CDI Recurrences. | Within 6 months of randomization | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced abdominal pain in each of their possible CDI recurrences. |
| Definite Recurrent CDI | Within 56 days of randomization | The occurrence of definite recurrent CDI within 56 days of randomization. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test. |
| Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization. | Within 6 months of randomization | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test. |
| Death | Within 56 days of randomization | The occurrence of death within 56 days of randomization. |
| Diarrhea That is Negative for C. Difficile by EIA Toxin Testing But Positive by PCR | Within 56 days of randomization | This is similar to possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test but positive by PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. |
| Occurrence of Urgency Among All Possible CDI Recurrences. | within 6 months from randomization | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced urgency in each of their possible CDI recurrences. The urgency is defined as the urgent need to pass stool, feelings of incomplete bowel control, or inability to control defecation. |
| Occurrence of Fecal Incontinence Among All Possible CDI Recurrences. | within 6 months from randomization | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced fecal incontinence in each of their possible CDI recurrences. Fecal incontinence is defined as having unintentional passing of stool (liquid or solid). |
| Occurrence of Altering Life Style Among All Possible CDI Recurrences | within 6 months of randomization | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they had to alter their life style (such as using pads) in each of the possible CDI recurrence. |
| Possible Recurrent CDI | Within 56 days of randomization | The occurrence of possible recurrent CDI within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. |
Countries
United States
Participant flow
Pre-assignment details
The study did not contain pre-assignment.
Participants by arm
| Arm | Count |
|---|---|
| Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT)
Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT | 76 |
| Placebo Placebo
Placebo: Oral capsule-delivered placebo | 77 |
| Total | 153 |
Baseline characteristics
| Characteristic | Total | Fecal Microbiota Therapy (FMT) | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 100 Participants | 56 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 20 Participants | 33 Participants |
| Age, Continuous | 66.5 years STANDARD_DEVIATION 13.74 | 69.2 years STANDARD_DEVIATION 12.31 | 63.9 years STANDARD_DEVIATION 14.63 |
| Albumin | 3.8 g/dL STANDARD_DEVIATION 0.6 | 3.7 g/dL STANDARD_DEVIATION 0.6 | 3.9 g/dL STANDARD_DEVIATION 0.6 |
| Race/Ethnicity, Customized Race : African-American or Black | 8 participants | 6 participants | 2 participants |
| Race/Ethnicity, Customized Race : American Indian or Alaska Native | 3 participants | 3 participants | 0 participants |
| Race/Ethnicity, Customized Race : Asian Indian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Race : Chinese | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Race : Filipino | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Race : Japanese | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Race : Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Race : Other Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Race : Other Race | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Race : White | 145 participants | 70 participants | 75 participants |
| Region of Enrollment United States | 153 participants | 76 participants | 77 participants |
| Sex: Female, Male Female | 21 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 132 Participants | 68 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 76 | 5 / 77 |
| other Total, other adverse events | 19 / 76 | 28 / 77 |
| serious Total, serious adverse events | 17 / 76 | 21 / 77 |
Outcome results
Primary
Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death
The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test.
Time frame: Within 56 days of randomization
Population: All randomized participants are analyzed according to the principle of intent-to-treat.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death | 25 Participants |
| Placebo | Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death | 23 Participants |
Secondary
Death
The occurrence of death within 56 days of randomization.
Time frame: Within 56 days of randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Death | 1 Participants |
| Placebo | Death | 1 Participants |
Secondary
Definite Recurrent CDI
The occurrence of definite recurrent CDI within 56 days of randomization. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test.
Time frame: Within 56 days of randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Definite Recurrent CDI | 6 Participants |
| Placebo | Definite Recurrent CDI | 7 Participants |
Secondary
Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR)
This is similar to a possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test and PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee.
Time frame: Within 56 days of randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR) | 9 Participants |
| Placebo | Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR) | 8 Participants |
Secondary
Diarrhea That is Negative for C. Difficile by EIA Toxin Testing But Positive by PCR
This is similar to possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test but positive by PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee.
Time frame: Within 56 days of randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Diarrhea That is Negative for C. Difficile by EIA Toxin Testing But Positive by PCR | 6 Participants |
| Placebo | Diarrhea That is Negative for C. Difficile by EIA Toxin Testing But Positive by PCR | 6 Participants |
Secondary
Frequency of Possible CDI Recurrences Within 6 Months of Randomization
A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee.
Time frame: Within 6 months of randomization
Population: Intent-to-treat
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fecal Microbiota Therapy (FMT) | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Have no possible CDI recurrence | 45 Participants |
| Fecal Microbiota Therapy (FMT) | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Have one possible CDI recurrence | 23 Participants |
| Fecal Microbiota Therapy (FMT) | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Have two possible CDI recurrences | 7 Participants |
| Fecal Microbiota Therapy (FMT) | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Have three possible CDI recurrences | 1 Participants |
| Placebo | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Have three possible CDI recurrences | 1 Participants |
| Placebo | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Have no possible CDI recurrence | 48 Participants |
| Placebo | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Have two possible CDI recurrences | 9 Participants |
| Placebo | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | Have one possible CDI recurrence | 19 Participants |
Secondary
Occurrence of Abdominal Pain Among All Possible CDI Recurrences.
A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced abdominal pain in each of their possible CDI recurrences.
Time frame: Within 6 months of randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Occurrence of Abdominal Pain Among All Possible CDI Recurrences. | 19 Recurrences |
| Placebo | Occurrence of Abdominal Pain Among All Possible CDI Recurrences. | 24 Recurrences |
Secondary
Occurrence of Altering Life Style Among All Possible CDI Recurrences
A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they had to alter their life style (such as using pads) in each of the possible CDI recurrence.
Time frame: within 6 months of randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Occurrence of Altering Life Style Among All Possible CDI Recurrences | 30 Recurrences |
| Placebo | Occurrence of Altering Life Style Among All Possible CDI Recurrences | 25 Recurrences |
Secondary
Occurrence of Fecal Incontinence Among All Possible CDI Recurrences.
A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced fecal incontinence in each of their possible CDI recurrences. Fecal incontinence is defined as having unintentional passing of stool (liquid or solid).
Time frame: within 6 months from randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Occurrence of Fecal Incontinence Among All Possible CDI Recurrences. | 21 Recurrences |
| Placebo | Occurrence of Fecal Incontinence Among All Possible CDI Recurrences. | 18 Recurrences |
Secondary
Occurrence of Urgency Among All Possible CDI Recurrences.
A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced urgency in each of their possible CDI recurrences. The urgency is defined as the urgent need to pass stool, feelings of incomplete bowel control, or inability to control defecation.
Time frame: within 6 months from randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Occurrence of Urgency Among All Possible CDI Recurrences. | 36 Recurrences |
| Placebo | Occurrence of Urgency Among All Possible CDI Recurrences. | 36 Recurrences |
Secondary
Possible Recurrent CDI
The occurrence of possible recurrent CDI within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee.
Time frame: Within 56 days of randomization
Population: intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Possible Recurrent CDI | 24 Participants |
| Placebo | Possible Recurrent CDI | 22 Participants |
Secondary
Quality of Life at 56 Day
The investigators will use a brief assessment of both overall and gastrointestinal health status, a previously validated instrument called Gastrointestinal Quality of Life Index (GIQLI). GIQLI takes value between 0 and 144, with higher score associated with better quality of life.
Time frame: 56 days from randomization
Population: Intent-to-treat \& complete-case
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fecal Microbiota Therapy (FMT) | Quality of Life at 56 Day | 111.42 units on a scale | Standard Deviation 21.25 |
| Placebo | Quality of Life at 56 Day | 115.67 units on a scale | Standard Deviation 19.15 |
Secondary
Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization.
A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test.
Time frame: Within 6 months of randomization
Population: Intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Therapy (FMT) | Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization. | 32 Participants |
| Placebo | Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization. | 31 Participants |