Recurrent C. Difficile Infection
Conditions
Brief summary
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
Detailed description
This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.
Interventions
BIOLOGICALLow fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
BIOLOGICALMid fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
BIOLOGICALHigh fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period * Female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure. * Subject willing to sign an informed consent form * Subject deemed likely to survive for ≥ 1 year after enrollment * Able to follow study procedure and follow-ups * Subjects' attending physician will provide non-transplant care for the subject * Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin * Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of vancomycin or metronidazole or fidaxomicin) since last bout of CDI * Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for overnight
Exclusion criteria
* Unable to take capsules orally * Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT * Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other than that found in fortified foods * Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT * Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as Assessed by Number of Participants With Nausea | 180 days |
| Safety as Assessed by Number of Participants With Vomiting | 180 days |
| Safety as Assessed by Number of Participants With Diarrhea | 180 days |
| Safety as Assessed by Number of Participants With Bloating | 180 days |
| Safety as Assessed by Number of Participants With Constipation | 180 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Recurrent C. Difficile Infection | 6 months |
Countries
United States
Participant flow
Pre-assignment details
2 of the 17 enrolled did not start treatment: one did not start treatment due to physician's concerns about patient taking bowel prep, and the second did not start treatment because of hospitalization.
Participants by arm
| Arm | Count |
|---|---|
| Low Fecal Microbiota Dose receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days | 4 |
| Mid Fecal Microbiota Dose receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment | 3 |
| High Fecal Microbiota Dose receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Low Fecal Microbiota Dose | Mid Fecal Microbiota Dose | High Fecal Microbiota Dose | Total |
|---|---|---|---|---|
| Age, Continuous | 49 years | 52 years | 72.5 years | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 3 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Patients with Inflammatory bowel disease | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 | 0 / 8 |
| other Total, other adverse events | 1 / 4 | 3 / 3 | 6 / 8 |
| serious Total, serious adverse events | 1 / 4 | 0 / 3 | 0 / 8 |
Outcome results
Primary
Safety as Assessed by Number of Participants With Bloating
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Bloating | 0 Participants |
| Mid Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Bloating | 0 Participants |
| High Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Bloating | 2 Participants |
Primary
Safety as Assessed by Number of Participants With Constipation
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Constipation | 0 Participants |
| Mid Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Constipation | 0 Participants |
| High Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Constipation | 1 Participants |
Primary
Safety as Assessed by Number of Participants With Diarrhea
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Diarrhea | 1 Participants |
| Mid Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Diarrhea | 0 Participants |
| High Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Diarrhea | 2 Participants |
Primary
Safety as Assessed by Number of Participants With Nausea
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Nausea | 0 Participants |
| Mid Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Nausea | 2 Participants |
| High Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Nausea | 1 Participants |
Primary
Safety as Assessed by Number of Participants With Vomiting
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Vomiting | 0 Participants |
| Mid Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Vomiting | 1 Participants |
| High Fecal Microbiota Dose | Safety as Assessed by Number of Participants With Vomiting | 0 Participants |
Secondary
Number of Participants With Recurrent C. Difficile Infection
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Fecal Microbiota Dose | Number of Participants With Recurrent C. Difficile Infection | 2 Participants |
| Mid Fecal Microbiota Dose | Number of Participants With Recurrent C. Difficile Infection | 0 Participants |
| High Fecal Microbiota Dose | Number of Participants With Recurrent C. Difficile Infection | 2 Participants |