Trial Outcomes & Findings for SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) (NCT NCT02437487)
NCT ID: NCT02437487
Last Updated: 2018-07-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
8 weeks after treatment.
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
SER-109
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
Placebo
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
30
|
|
Overall Study
Actual Treatment Received
|
60
|
29
|
|
Overall Study
Intention-to-Treat Population
|
59
|
30
|
|
Overall Study
COMPLETED
|
32
|
16
|
|
Overall Study
NOT COMPLETED
|
27
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
Baseline characteristics by cohort
| Measure |
SER-109
n=59 Participants
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
Placebo
n=30 Participants
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 16.60 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 14.02 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 15.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (kg/m2)
|
27.72 kg/m^2
STANDARD_DEVIATION 6.402 • n=5 Participants
|
27.65 kg/m^2
STANDARD_DEVIATION 5.744 • n=7 Participants
|
27.70 kg/m^2
STANDARD_DEVIATION 6.150 • n=5 Participants
|
|
Number of Previous CDI Episodes
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Number of Previous CDI Episodes
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Number of Previous CDI Episodes
3
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Number of Previous CDI Episodes
4
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Number of Previous CDI Episodes
5 or more
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Stool Frequency
0-2 per day
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Stool Frequency
3 per day
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Stool Frequency
4-5 per day
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Stool Frequency
6-9 per day
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Stool Frequency
10 or more per day
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Stool Frequency
Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
White Blood Cells Category
less than 12,000
|
18 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
White Blood Cells Category
12,001 to 15,000
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
White Blood Cells Category
15,001 or more
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
White Blood Cells Category
Unknown
|
40 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Albumin < 2.5 mg/dL
Yes
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Albumin < 2.5 mg/dL
No
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Albumin < 2.5 mg/dL
Unknown
|
38 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after treatment.Population: Intention-To-Treat (ITT) Population
Outcome measures
| Measure |
SER-109
n=59 Participants
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
Placebo
n=30 Participants
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
|---|---|---|
|
Number of Subjects With CDI Recurrence
|
26 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Recurrence of CDI up to 24 weeks after treatment.Population: Intention to Treat (ITT) Population
Kaplan-Meier estimate of median number of days to recurrence
Outcome measures
| Measure |
SER-109
n=59 Participants
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
Placebo
n=30 Participants
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
|---|---|---|
|
Time to Recurrence of CDI
|
NA days
Interval 35.0 to
Insufficient number of participants with events.
|
NA days
Interval 14.0 to
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Intention-to-Treat (ITT) Population
Outcome measures
| Measure |
SER-109
n=59 Participants
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
Placebo
n=30 Participants
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
|---|---|---|
|
Number of Subjects With CDI Recurrence
|
22 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intention-to-Treat (ITT) Population
Outcome measures
| Measure |
SER-109
n=59 Participants
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
Placebo
n=30 Participants
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
|---|---|---|
|
Number of Subjects With CDI Recurrence
|
26 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Intention-to-Treat (ITT) Population
Outcome measures
| Measure |
SER-109
n=59 Participants
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
Placebo
n=30 Participants
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
|---|---|---|
|
Number of Subjects With CDI Recurrence
|
31 Participants
|
17 Participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
SER-109
Serious events: 9 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=29 participants at risk
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
SER-109
n=60 participants at risk
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Drug Overdose
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Basilic Vein Thrombosis
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Worsening Abdominal Pain
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Mental Status Changes due to Dehydration
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
GI Bleeding
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
General disorders
Chest Pain
|
0.00%
0/29 • 24 weeks
|
3.3%
2/60 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Loose stools
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 3 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute On Chronic Respiratory Failure
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Cellulitis of Left Lower Leg
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 3 • 24 weeks
|
|
Cardiac disorders
CHF Exacerbation
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 2 • 24 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Nervous system disorders
Worsening of Headache
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Vascular disorders
LLE DVT
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute on Chronic Hypoxia
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 2 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Foot Ulcer
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 2 • 24 weeks
|
|
Reproductive system and breast disorders
Cough
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
General disorders
Blockage of Dialysis Stunt
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
General disorders
Enlarged Pelvic Mass
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Vascular disorders
DVT Left Leg
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Non Small Cell Lung Cancer (NSCLC)
|
0.00%
0/29 • 24 weeks
|
1.7%
1/60 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Altered Mental Status
|
3.4%
1/29 • Number of events 1 • 24 weeks
|
0.00%
0/60 • 24 weeks
|
|
Nervous system disorders
Episode of Unresponsiveness
|
3.4%
1/29 • Number of events 1 • 24 weeks
|
0.00%
0/60 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
1/29 • Number of events 1 • 24 weeks
|
0.00%
0/60 • 24 weeks
|
|
General disorders
Worsening of Generalized Weakness
|
3.4%
1/29 • Number of events 1 • 24 weeks
|
0.00%
0/60 • 24 weeks
|
Other adverse events
| Measure |
Placebo
n=29 participants at risk
Placebo
Placebo: Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
|
SER-109
n=60 participants at risk
SER 109 (1 × 108 SporQs)
SER-109: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
13.8%
4/29 • 24 weeks
|
25.0%
15/60 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.8%
4/29 • 24 weeks
|
21.7%
13/60 • 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • 24 weeks
|
11.7%
7/60 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • 24 weeks
|
10.0%
6/60 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29 • 24 weeks
|
5.0%
3/60 • 24 weeks
|
|
General disorders
Pyrexia
|
6.9%
2/29 • 24 weeks
|
3.3%
2/60 • 24 weeks
|
|
General disorders
Asthenia
|
6.9%
2/29 • 24 weeks
|
1.7%
1/60 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • 24 weeks
|
8.3%
5/60 • 24 weeks
|
Additional Information
Dr. Michele Trucksis, Chief Medical Officer
Seres Therapeutics
Phone: (617) 945-9626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Proposed publications must be submitted to Sponsor for review at least 30 days prior to publication. Sponsor can require removal of confidential information other than study data and Site/Investigator agree to consider Sponsor's suggestions with respect to the presentation of study data. Sponsor can force publication to be deferred for a period of up to 60 days in order to file any patents.
- Publication restrictions are in place
Restriction type: OTHER