Trial Outcomes & Findings for Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea (NCT NCT02318992)
NCT ID: NCT02318992
Last Updated: 2024-05-23
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
79 participants
Primary outcome timeframe
6 months
Results posted on
2024-05-23
Participant Flow
79 were enrolled; however only 78 started--this is because one person who enrolled withdrew before treatment initiation due to insurance problem.
Participant milestones
| Measure |
Fecal Microbiota_Fresh
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (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 (250 milliliters (mL)) was used within 2 hours of preparation (Fresh).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Frozen
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (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 (250mL) was kept at -80 degrees celsius (C) freezer labeled with identity (ID) and expiration date which was 6 months after preparation day (Frozen).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Lyophilized
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 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 (250 milliliters (mL)) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 degrees celsius (C) and were used within 6 months after preparation day.
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
24
|
|
Overall Study
COMPLETED
|
25
|
25
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fecal Microbiota_Fresh
n=27 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (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 (250mL) was used within 2 hours of preparation (Fresh).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Frozen
n=27 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 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 (250mL) was kept at -80 degrees celsius (C) freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Lyophilized
n=24 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 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 (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 degrees celsius (C) and were used within 6 months after preparation day.
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 20.04 • n=27 Participants
|
63 years
STANDARD_DEVIATION 13.79 • n=27 Participants
|
59 years
STANDARD_DEVIATION 19.27 • n=24 Participants
|
63 years
STANDARD_DEVIATION 17.90 • n=78 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=27 Participants
|
18 Participants
n=27 Participants
|
13 Participants
n=24 Participants
|
52 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=27 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=24 Participants
|
26 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
24 Participants
n=24 Participants
|
78 Participants
n=78 Participants
|
|
Number of Patients with Inflammatory bowel disease
|
7 Participants
n=27 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=24 Participants
|
16 Participants
n=78 Participants
|
|
Number of Patients with Ulcerative Colitis
|
6 Participants
n=27 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=24 Participants
|
12 Participants
n=78 Participants
|
|
Number of Patients with Crohn's Disease
|
1 Participants
n=27 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=78 Participants
|
|
Number of Patients used Anti-C. difficile infection (CDI) treatment 6 months before the procedure
|
25 Participants
n=27 Participants
|
24 Participants
n=27 Participants
|
24 Participants
n=24 Participants
|
73 Participants
n=78 Participants
|
|
duration since last Clostridium difficile infection (CDI) bout in 0.5 month increments
|
2 half months
STANDARD_DEVIATION 2.06 • n=27 Participants
|
2 half months
STANDARD_DEVIATION 1.97 • n=27 Participants
|
2 half months
STANDARD_DEVIATION 1.36 • n=24 Participants
|
2 half months
STANDARD_DEVIATION 1.80 • n=78 Participants
|
|
total number Clostridium difficile infection (CDI) bouts before fecal microbiota transplantation
|
4 counts
STANDARD_DEVIATION 0.87 • n=27 Participants
|
4 counts
STANDARD_DEVIATION 0.93 • n=27 Participants
|
4 counts
STANDARD_DEVIATION 2.24 • n=24 Participants
|
4 counts
STANDARD_DEVIATION 1.35 • n=78 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: One subject in the Fecal Microbiota\_Fresh group was lost to follow up.
Any 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 |
Fecal Microbiota_Fresh
n=26 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250mL) was used within 2 hours of preparation (Fresh).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Frozen
n=27 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250mL) was kept at -80 C freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Lyophilized
n=24 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day.
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
|---|---|---|---|
|
Safety of Fresh, Frozen or Lyophilized Intestinal Bacteria From Healthy Donors Given by Colonoscopy for Therapy in Subjects With Recurrent C. Difficile Associated Diarrhea (RCDAD) as Assessed by Number of Participants Who Any Adverse Event
|
15 Participants
|
23 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: One subject in the Fecal Microbiota\_Fresh group was lost to follow up.
a subsequent bout of C-diff associated diarrhea was defined as diarrhea, C. difficile toxins positive and using anti-C. difficile antibiotic treatment
Outcome measures
| Measure |
Fecal Microbiota_Fresh
n=26 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250mL) was used within 2 hours of preparation (Fresh).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Frozen
n=27 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250mL) was kept at -80 C freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Lyophilized
n=24 Participants
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day.
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
|---|---|---|---|
|
Number of Participants Who Had a Subsequent Bout of C-diff Associated Diarrhea
|
1 Participants
|
3 Participants
|
7 Participants
|
Adverse Events
Fecal Microbiota_Fresh
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fecal Microbiota_Frozen
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Fecal Microbiota_Lyophilized
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fecal Microbiota_Fresh
n=26 participants at risk
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250 mL) was used within 2 hours of preparation (Fresh).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Frozen
n=27 participants at risk
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250 mL) was kept at -80 C freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Lyophilized
n=24 participants at risk
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250 mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day.
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
|---|---|---|---|
|
Infections and infestations
Urosepsis
|
0.00%
0/26 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
0.00%
0/27 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
4.2%
1/24 • Number of events 1 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
|
Gastrointestinal disorders
Colitis and enteritis with cholelithiasis
|
0.00%
0/26 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
3.7%
1/27 • Number of events 1 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
0.00%
0/24 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
Other adverse events
| Measure |
Fecal Microbiota_Fresh
n=26 participants at risk
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250 mL) was used within 2 hours of preparation (Fresh).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Frozen
n=27 participants at risk
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250 mL) was kept at -80 C freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen).
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
Fecal Microbiota_Lyophilized
n=24 participants at risk
Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 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 (250 mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day.
Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy.
|
|---|---|---|---|
|
Gastrointestinal disorders
gastrointestinal complaints
|
3.8%
1/26 • Number of events 1 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
3.7%
1/27 • Number of events 1 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
20.8%
5/24 • Number of events 5 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
|
Renal and urinary disorders
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
3.7%
1/27 • Number of events 1 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
0.00%
0/24 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
|
Blood and lymphatic system disorders
blood clot
|
0.00%
0/26 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
0.00%
0/27 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
4.2%
1/24 • Number of events 1 • 6 months
Although 27 started in the Fecal Microbiota\_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota\_Fresh group was lost to follow up.
|
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