Trial Outcomes & Findings for Fecal Microbiota Transplantation to Treat Recurrent C. Difficile Associated Diarrhea Via Retention Enema or Oral Route (NCT NCT02449174)
NCT ID: NCT02449174
Last Updated: 2019-03-25
Results Overview
any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
69 participants
Primary outcome timeframe
6 months after the procedure
Results posted on
2019-03-25
Participant Flow
One patient who enrolled never started treatment.
Participant milestones
| Measure |
Frozen Microbiota
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema
Frozen Microbiota: Frozen Microbiota will be delivered via enema route.
|
Lyophilized Microbiota
Lyophilized Microbiota\_Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally
Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
32
|
|
Overall Study
COMPLETED
|
36
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Frozen Microbiota
n=36 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema
Frozen Microbiota: Frozen Microbiota will be delivered via enema route.
|
Lyophilized Microbiota
n=32 Participants
Lyophilized Microbiota\_Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally
Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=36 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
15 Participants
n=36 Participants
|
15 Participants
n=32 Participants
|
30 Participants
n=68 Participants
|
|
Age, Categorical
Age · >=65 years
|
21 Participants
n=36 Participants
|
17 Participants
n=32 Participants
|
38 Participants
n=68 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=36 Participants
|
21 Participants
n=32 Participants
|
47 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=36 Participants
|
11 Participants
n=32 Participants
|
21 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
36 Participants
n=36 Participants
|
32 Participants
n=32 Participants
|
68 Participants
n=68 Participants
|
|
Patients with IBD comorbidity
|
5 Participants
n=36 Participants
|
6 Participants
n=32 Participants
|
11 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 6 months after the procedureany untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)
Outcome measures
| Measure |
Frozen Microbiota
n=36 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema
Frozen Microbiota: Frozen Microbiota will be delivered via enema route.
|
Lyophilized Microbiota
n=32 Participants
Lyophilized Microbiota\_Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally
Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.
|
|---|---|---|
|
Safety as Assessed by Number of Participants With Any Adverse Events (AE)s
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 60 days after the procedurePopulation: subjects had more than 3 episodes of C. difficile infection and were treated with FMT
diarrhea was defined as more than 3 episodes of loose/watery stools in 2 consecutive days
Outcome measures
| Measure |
Frozen Microbiota
n=36 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema
Frozen Microbiota: Frozen Microbiota will be delivered via enema route.
|
Lyophilized Microbiota
n=32 Participants
Lyophilized Microbiota\_Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally
Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.
|
|---|---|---|
|
Number of Participants Who Continue to Have Diarrhea and C. Difficile Toxin Following Fecal Microbiota Transplantation From a Healthy Donor
|
4 Participants
|
5 Participants
|
Adverse Events
Frozen Microbiota
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Lyophilized Microbiota
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Frozen Microbiota
n=36 participants at risk
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema
Frozen Microbiota: Frozen Microbiota will be delivered via enema route.
|
Lyophilized Microbiota
n=32 participants at risk
Lyophilized Microbiota\_Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally
Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.
|
|---|---|---|
|
Nervous system disorders
brain hematoma
|
2.8%
1/36 • Number of events 1 • 6 months
|
0.00%
0/32 • 6 months
|
|
Infections and infestations
urine track infection
|
5.6%
2/36 • Number of events 2 • 6 months
|
0.00%
0/32 • 6 months
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/36 • 6 months
|
6.2%
2/32 • Number of events 2 • 6 months
|
|
Nervous system disorders
Stoke
|
0.00%
0/36 • 6 months
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/36 • 6 months
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal related symptoms
|
2.8%
1/36 • Number of events 1 • 6 months
|
3.1%
1/32 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Frozen Microbiota
n=36 participants at risk
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema
Frozen Microbiota: Frozen Microbiota will be delivered via enema route.
|
Lyophilized Microbiota
n=32 participants at risk
Lyophilized Microbiota\_Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally
Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.
|
|---|---|---|
|
Gastrointestinal disorders
gastrointestinal complaints
|
5.6%
2/36 • Number of events 2 • 6 months
|
9.4%
3/32 • Number of events 3 • 6 months
|
|
General disorders
headache
|
2.8%
1/36 • Number of events 1 • 6 months
|
0.00%
0/32 • 6 months
|
|
General disorders
outpatient surgey for fracture
|
0.00%
0/36 • 6 months
|
3.1%
1/32 • Number of events 1 • 6 months
|
|
Infections and infestations
Bladder Infection
|
2.8%
1/36 • Number of events 1 • 6 months
|
0.00%
0/32 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
breathing difficulty
|
2.8%
1/36 • Number of events 1 • 6 months
|
0.00%
0/32 • 6 months
|
Additional Information
Dr. Herbert DuPont
University of Texas School of Public Health
Phone: 713 500 9366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place