Trial Outcomes & Findings for The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation (NCT NCT03621657)
NCT ID: NCT03621657
Last Updated: 2021-03-15
Results Overview
Assess microbial composition of stool using 16s targeted sequencing and shotgun metagenomics
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
60 days
Results posted on
2021-03-15
Participant Flow
Participant milestones
| Measure |
Low Dose FMT Capsule DE
FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic
Low Dose FMT Capsule DE: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course.
|
Placebo Oral Capsule
Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic
Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment.
|
Single Dose FMT Capsule DE
FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.
Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation
Baseline characteristics by cohort
| Measure |
Low Dose FMT Capsule DE
FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic
Low Dose FMT Capsule DE: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course.
|
Placebo Oral Capsule
Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic
Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment.
|
Single Dose FMT Capsule DE
n=1 Participants
FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.
Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: There are no results due to low enrollment (N=1).
Assess microbial composition of stool using 16s targeted sequencing and shotgun metagenomics
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: There are no results due to low enrollment (N=1)
Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0, including serious adverse events, will be assessed. We will also assess proportion of newly diagnosed infectious diseases, which are considered adverse events of special interest (AESI) after randomization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: There are no results due to low enrollment (N=1)
Collection of CDI infection rates from baseline to end of study and comparison between both oral FMT groups versus placebo.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 daysPopulation: There are no results due to low enrollment (N=1)
C. difficile colonization will be detected in stool samples submitted at baseline through end of study. If patients' become colonized, time from randomization to colonization is collected. Comparisons are made between the oral FMT groups and placebo.
Outcome measures
Outcome data not reported
Adverse Events
Low Dose FMT Capsule DE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single Dose FMT Capsule DE
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose FMT Capsule DE
FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic
Low Dose FMT Capsule DE: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course.
|
Placebo Oral Capsule
Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic
Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment.
|
Single Dose FMT Capsule DE
n=1 participants at risk
FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.
Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
—
0/0 • 6 months
Insufficient participant population, low enrollment
|
—
0/0 • 6 months
Insufficient participant population, low enrollment
|
100.0%
1/1 • Number of events 1 • 6 months
Insufficient participant population, low enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place