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SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)

ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02437487
Acronym
ECOSPOR
Enrollment
89
Registered
2015-05-07
Start date
2015-05-31
Completion date
2016-10-31
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile

Brief summary

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

Detailed description

ECOSPOR is a Phase 2, multicenter, randomized, double blind, placebo controlled clinical study with 2 treatment arms (SER-109 or placebo). Patients who have diarrhea and a positive C. difficile test result on a stool sample, and who have responded to standard of care antibiotic treatment will receive study drug on Day 1. Those patients who experience a recurrence of CDI up to 8 weeks after SER 109 or placebo treatment will be offered an opportunity to enroll in an open label SER 109 extension study (Study SERES 005).

Interventions

DRUGSER-109

SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.

DRUGPlacebo

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.

Sponsors

Syneos Health
CollaboratorOTHER
Seres Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Signed informed consent, indicating that the patient understands the purpose of and procedures required for the study. Patients who are unable to provide informed consent will not be included in the study. 2. Male or female patients ≥ 18 years. 3. ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode with documentation of ≥ 2 episodes.

Exclusion criteria

1. Female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study. 2. Known or suspected toxic megacolon and/or known small bowel ileus. 3. Active irritable bowel syndrome with diarrhea within the previous 12 months. 4. Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery. 5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 24 months. 6. Admitted to or expected to be admitted to an acute care facility or intensive care unit for medical reasons (not just boarding). Patients discharged from an acute care facility before Day 1 or residing in nursing homes or rehabilitation facilities may be enrolled. 7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).

Design outcomes

Primary

MeasureTime frame
Number of Subjects With CDI Recurrence8 weeks after treatment.

Secondary

MeasureTime frameDescription
Time to Recurrence of CDIRecurrence of CDI up to 24 weeks after treatment.Kaplan-Meier estimate of median number of days to recurrence
Number of Subjects With CDI Recurrence4 Weeks—

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
59
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.
30
Total89

Baseline characteristics

CharacteristicTotalSER-109Placebo
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
46 Participants31 Participants15 Participants
Age, Categorical
Between 18 and 65 years
43 Participants28 Participants15 Participants
Age, Continuous64.5 years
STANDARD_DEVIATION 15.74
63.7 years
STANDARD_DEVIATION 16.6
66.1 years
STANDARD_DEVIATION 14.02
Albumin < 2.5 mg/dL
No
28 Participants20 Participants8 Participants
Albumin < 2.5 mg/dL
Unknown
58 Participants38 Participants20 Participants
Albumin < 2.5 mg/dL
Yes
3 Participants1 Participants2 Participants
Body Mass Index (kg/m2)27.70 kg/m^2
STANDARD_DEVIATION 6.15
27.72 kg/m^2
STANDARD_DEVIATION 6.402
27.65 kg/m^2
STANDARD_DEVIATION 5.744
Number of Previous CDI Episodes
1
0 Participants0 Participants0 Participants
Number of Previous CDI Episodes
2
0 Participants0 Participants0 Participants
Number of Previous CDI Episodes
3
48 Participants28 Participants20 Participants
Number of Previous CDI Episodes
4
26 Participants21 Participants5 Participants
Number of Previous CDI Episodes
5 or more
15 Participants10 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants3 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
83 Participants54 Participants29 Participants
Sex: Female, Male
Female
60 Participants40 Participants20 Participants
Sex: Female, Male
Male
29 Participants19 Participants10 Participants
Stool Frequency
0-2 per day
0 Participants0 Participants0 Participants
Stool Frequency
10 or more per day
19 Participants11 Participants8 Participants
Stool Frequency
3 per day
5 Participants5 Participants0 Participants
Stool Frequency
4-5 per day
39 Participants27 Participants12 Participants
Stool Frequency
6-9 per day
22 Participants14 Participants8 Participants
Stool Frequency
Unknown
4 Participants2 Participants2 Participants
White Blood Cells Category
12,001 to 15,000
3 Participants1 Participants2 Participants
White Blood Cells Category
15,001 or more
0 Participants0 Participants0 Participants
White Blood Cells Category
less than 12,000
25 Participants18 Participants7 Participants
White Blood Cells Category
Unknown
61 Participants40 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 29
other
Total, other adverse events
33 / 6013 / 29
serious
Total, serious adverse events
9 / 603 / 29

Outcome results

Primary

Number of Subjects With CDI Recurrence

Time frame: 8 weeks after treatment.

Population: Intention-To-Treat (ITT) Population

ArmMeasureValue (NUMBER)
SER-109Number of Subjects With CDI Recurrence26 participants
PlaceboNumber of Subjects With CDI Recurrence16 participants
95% CI: [0.7919, 1.8849]
Secondary

Number of Subjects With CDI Recurrence

Time frame: 4 Weeks

Population: Intention-to-Treat (ITT) Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SER-109Number of Subjects With CDI Recurrence22 Participants
PlaceboNumber of Subjects With CDI Recurrence14 Participants
95% CI: [0.7668, 2.0785]
Secondary

Number of Subjects With CDI Recurrence

Time frame: 12 Weeks

Population: Intention-to-Treat (ITT) Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SER-109Number of Subjects With CDI Recurrence26 Participants
PlaceboNumber of Subjects With CDI Recurrence16 Participants
95% CI: [0.7919, 1.8849]
Secondary

Number of Subjects With CDI Recurrence

Time frame: 24 Weeks

Population: Intention-to-Treat (ITT) Population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SER-109Number of Subjects With CDI Recurrence31 Participants
PlaceboNumber of Subjects With CDI Recurrence17 Participants
95% CI: [0.7383, 1.6029]
Secondary

Time to Recurrence of CDI

Kaplan-Meier estimate of median number of days to recurrence

Time frame: Recurrence of CDI up to 24 weeks after treatment.

Population: Intention to Treat (ITT) Population

ArmMeasureValue (MEDIAN)
SER-109Time to Recurrence of CDINA days
PlaceboTime to Recurrence of CDINA days

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026