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History of Changes for Study: NCT03183128
ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection (ECOSPORIII)
Latest version (submitted April 17, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 8, 2017 None (earliest Version on record)
2 June 9, 2017 Study Status
3 June 12, 2017 Recruitment Status, Study Status and Contacts/Locations
4 May 31, 2018 Study Status and Contacts/Locations
5 March 29, 2019 Contacts/Locations and Study Status
6 May 2, 2019 Study Status, Study Design and Study Description
7 April 17, 2020 Recruitment Status, Study Status and Contacts/Locations
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Study NCT03183128
Submitted Date:  June 12, 2017 (v3)

Study Identification
Unique Protocol ID: SERES-012
Brief Title: ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection (ECOSPORIII)
Official Title: A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults
Secondary IDs:
Study Status
Record Verification: June 2017
Overall Status: Recruiting
Study Start: June 2017
Primary Completion: February 2019 [Anticipated]
Study Completion: June 2019 [Anticipated]
First Submitted: June 8, 2017
First Submitted that
Met QC Criteria:
June 8, 2017
First Posted: June 9, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 12, 2017
Last Update Posted: June 14, 2017 [Actual]
Sponsor/Collaborators
Sponsor: Seres Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Study Description
Brief Summary: Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.
Detailed Description:

ECOSPOR III is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, and efficacy of SER-109 versus placebo in adult subjects 18 years of age or older with recurrent CDI, defined as: a history of ≥ 3 CDI episodes within 9 months, inclusive of the current episode. This study is designed to demonstrate the superiority of SER-109 versus placebo to reduce recurrence of Clostridium difficile infection (CDI) in adults who have received antibacterial drug treatment for recurrent CDI (RCDI), based on the proportion of subjects experiencing a CDI recurrence requiring antibiotic treatment up to 8 weeks after initiation of treatment. Approximately 320 subjects with a history of CDI, diarrhea and a positive C. difficile toxin test result on a stool sample, who have responded to standard-of-care (SOC) antibiotic treatment will be enrolled. Subjects will be randomly assigned, in a 1:1 ratio, to 1 of 2 treatment groups (Treatment Group I [SER-109] or Treatment Group II [Placebo]) and stratified by age (<65 years; ≥65 years), as well as antibiotic regimen for the qualifying episode (vancomycin; fidaxomicin).

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II.

Subjects with confirmed CDI recurrence, as defined in the Protocol, up to 8 weeks after administration of SER-109 or placebo treatment, and who have completed their Week 8 visit, may be eligible to enroll in the open- label SER-109 extension study (Study SERES-013).

Conditions
Conditions: Clostridium Difficile Infection
Keywords:
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 320 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Experimental: SER-109
SER -109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
Drug: SER-109

SER -109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors

Other Names:

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Comparator: Placebo
Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline
Drug: Placebo
Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
Outcome Measures
Primary Outcome Measures:
1. Recurrence of CDI up to 8 weeks after treatment
Recurrence of CDI

[Time Frame: Up to Week 8]
Secondary Outcome Measures:
2. Safety and tolerability of SER-109 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings
Safety and tolerability of SER-109 Safety and tolerability

[Time Frame: Up to Week 24]
3. Time to recurrence of CDI
Time to recurrence of CDI

[Time Frame: Up to Week 24]
4. Recurrence of CDI up to 4, 12 and 24 weeks after treatment
Recurrence of CDI

[Time Frame: Up to 4, 12 and 24 weeks after treatment]
Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
  2. Male or female subject ≥ 18 years of age.
  3. A qualifying episode of CDI as defined by:
    1. ≥ 3 unformed stools per day for 2 consecutive days
    2. A positive C. difficile stool toxin assay.
    3. The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin [125 mg QID] and/or fidaxomicin [200 mg BID]).
    4. An adequate clinical response following SOC antibiotic therapy, defined as (<3 unformed stools in 24 hours) for 2 or more consecutive days before randomization.

Exclusion Criteria:

  1. Female subjects 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. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
  4. Absolute neutrophil count of <500 cells/ml3
  5. Major gastrointestinal surgery (e.g. 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 (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
  6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
  7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
  8. Any history of fecal microbiota transplantation (FMT).
Contacts/Locations
Central Contact: Michele Trucksis, PhD, MD
Telephone: 617-203-3367
Email: mtrucksis@serestherapeutics.com
Study Officials: Michele Trucksis, PhD, MD
Study Director
Seres Therapeutics, Inc.
Locations: United States, Montana
Mercury Street Medical
[Recruiting]
Butte, Montana, United States, 59701
Contact: John Pullman, MD 406-723-1300
IPDSharing
Plan to Share IPD: No
References
Citations:
Links:
Available IPD/Information:

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