Trial Outcomes & Findings for Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI) (NCT NCT03298048)
NCT ID: NCT03298048
Last Updated: 2020-03-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
180 days
Results posted on
2020-03-06
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
8
|
|
Overall Study
COMPLETED
|
4
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
Baseline characteristics by cohort
| Measure |
Low Fecal Microbiota Dose
n=4 Participants
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
|
Mid Fecal Microbiota Dose
n=3 Participants
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
|
High Fecal Microbiota Dose
n=8 Participants
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
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
52 years
n=7 Participants
|
72.5 years
n=5 Participants
|
68 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
15 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
|
1 Participants
n=5 Participants
|
1 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
|
Number of Patients with Inflammatory bowel disease
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Low Fecal Microbiota Dose
n=4 Participants
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
|
Mid Fecal Microbiota Dose
n=3 Participants
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
|
High Fecal Microbiota Dose
n=8 Participants
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
|
|---|---|---|---|
|
Safety as Assessed by Number of Participants With Nausea
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Low Fecal Microbiota Dose
n=4 Participants
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
|
Mid Fecal Microbiota Dose
n=3 Participants
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
|
High Fecal Microbiota Dose
n=8 Participants
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
|
|---|---|---|---|
|
Safety as Assessed by Number of Participants With Vomiting
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Low Fecal Microbiota Dose
n=4 Participants
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
|
Mid Fecal Microbiota Dose
n=3 Participants
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
|
High Fecal Microbiota Dose
n=8 Participants
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
|
|---|---|---|---|
|
Safety as Assessed by Number of Participants With Diarrhea
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Low Fecal Microbiota Dose
n=4 Participants
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
|
Mid Fecal Microbiota Dose
n=3 Participants
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
|
High Fecal Microbiota Dose
n=8 Participants
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
|
|---|---|---|---|
|
Safety as Assessed by Number of Participants With Bloating
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Low Fecal Microbiota Dose
n=4 Participants
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
|
Mid Fecal Microbiota Dose
n=3 Participants
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
|
High Fecal Microbiota Dose
n=8 Participants
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
|
|---|---|---|---|
|
Safety as Assessed by Number of Participants With Constipation
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Low Fecal Microbiota Dose
n=4 Participants
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
|
Mid Fecal Microbiota Dose
n=3 Participants
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
|
High Fecal Microbiota Dose
n=8 Participants
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
|
|---|---|---|---|
|
Number of Participants With Recurrent C. Difficile Infection
|
2 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Low Fecal Microbiota Dose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Mid Fecal Microbiota Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
High Fecal Microbiota Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Fecal Microbiota Dose
n=4 participants at risk
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
|
Mid Fecal Microbiota Dose
n=3 participants at risk
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
|
High Fecal Microbiota Dose
n=8 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/8 • 6 months
|
Other adverse events
| Measure |
Low Fecal Microbiota Dose
n=4 participants at risk
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
|
Mid Fecal Microbiota Dose
n=3 participants at risk
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
|
High Fecal Microbiota Dose
n=8 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
2/8 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/4 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/4 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/4 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
2/8 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/4 • 6 months
|
0.00%
0/3 • 6 months
|
12.5%
1/8 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place