Clostridium Difficile InfectionPhase 3ECOSPORIIINCT03183128
ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
A Phase 3 study testing SER-109 in people with Clostridium Difficile Infection, run by Seres Therapeutics, Inc. at 56 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- SER-109
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 56 sitesin 2 countries
- Study dates
- 10 Jul 2017to 29 Sep 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject or their legally authorized representative must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
- Male or female subject ≥ 18 years of age.
- A qualifying episode of CDI as defined by:
- ≥ 3 unformed stools per day for 2 consecutive days
- A positive C. difficile stool toxin assay.
- 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]).
- An adequate clinical response following SOC antibiotic therapy, defined as (<3 unformed stools in 24 hours) for 2 or more consecutive days before randomization.
Main Exclusion Criteria:
- Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
- Known or suspected toxic megacolon and/or known small bowel ileus.
- 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.
- Absolute neutrophil count of <500 cells/ml^3
- 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).
- 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.
- 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).
- Any history of fecal microbiota transplantation (FMT) within the previous 3 months.
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
United States51 sites
(Investigator site)
Annapolis, Maryland, 21401
(Investigator site)
Athens, Georgia, 30607
(Investigator site)
Atlanta, Georgia, 30322
(Investigator site)
Boston, Massachusetts, 02144
(Investigator site)
Bountiful, Utah, 84010
(Investigator site)
Buffalo, New York, 14215
(Investigator site)
Butte, Montana, 59701
(Investigator site)
Centerville, Ohio, 45459
(Investigator site)
Charlottesville, Virginia, 22908
(Investigator site)
Chevy Chase, Maryland, 20814
(Investigator site)
Cleveland, Ohio, 44195
(Investigator site)
Columbus, Ohio, 43215
(Investigator site)
Detroit, Michigan, 48202
(Investigator site)
Evansville, Indiana, 47714
(Investigator site)
Greenville, North Carolina, 27834
(Investigator site)
Hamden, Connecticut, 06518
(Investigator site)
Houston, Texas, 77098
(Investigator site)
Idaho Falls, Idaho, 83404
(Investigator site)
Iowa City, Iowa, 52242
(Investigator site)
Jacksonville, Florida, 32256
(Investigator site)
Jeffersonville, Indiana, 47130
(Investigator site)
Kansas City, Kansas, 66160
(Investigator site)
Kinston, North Carolina, 28501
(Investigator site)
Las Vegas, Nevada, 89119
(Investigator site)
Marietta, Georgia, 30060
(Investigator site)
Mather, California, 95655
(Investigator site)
Miami, Florida, 33015
(Investigator site)
Miami, Florida, 33155
(Investigator site)
Mountain View, California, 94040
(Investigator site)
New Orleans, Louisiana, 70121
(Investigator site)
North Little Rock, Arkansas, 72117
(Investigator site)
Northridge, California, 91324
(Investigator site)
Pembroke Pines, Florida, 33024
(Investigator site)
Pembroke Pines, Florida, 33026
(Investigator site)
Pittsburgh, Pennsylvania, 15213
(Investigator site)
Raleigh, North Carolina, 27607
(Investigator site)
Reston, Virginia, 20191
(Investigator site)
Riverdale, Georgia, 30274
(Investigator site)
Riverton, Utah, 84065
(Investigator site)
Royal Oak, Michigan, 48073
(Investigator site)
Sacramento, California, 95817
(Investigator site)
San Antonio, Texas, 78234
(Investigator site)
Sandy Springs, Georgia, 30342
(Investigator site)
Sayre, Pennsylvania, 18840
(Investigator site)
Simi Valley, California, 93065
(Investigator site)
Southlake, Texas, 76092
(Investigator site)
Springfield, Illinois, 62703
(Investigator site)
St Louis, Missouri, 63141
(Investigator site)
Upland, California, 91786
(Investigator site)
Washington D.C., District of Columbia, 20007
(Investigator site)
Worcester, Massachusetts, 01655
Canada5 sites
(Investigator site)
Calgary, Alberta, T2N 2T9
(Investigator site)
Chicoutimi, Quebec, G7H 7Y8
(Investigator site)
London, Ontario, N6A 4V2
(Investigator site)
Vancouver, British Columbia, V5Z 1M9
(Investigator site)
Victoria, British Columbia, V8R 1J8
About this study
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
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 as determined by a toxin assay in adults up to 8 weeks after initiation of treatment.
Read the 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 12 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 188 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, may be eligible to enroll in the open-label SER-109 extension study (Study SERES-013).
- Conditions
- Clostridium Difficile Infection
- Being tested
- SER-109, Placebo
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SER-109Biological
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
PlaceboDrug
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(0.9%).
| Study group | Role | What they receive |
|---|---|---|
| SER-109 | Experimental | Received oral dose of SER-109 Receives: Biological: SER-109 |
| Placebo | Placebo comparator | Received matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of CDI up to 8 Weeks
Recurrence of CDI up to 8 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Measured: Up to Week 8
Secondary outcomes (1)
Recurrence of CDI up to 4, 12 and 24 Weeks
Recurrence of CDI up to 4, 12 and 24 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Measured: Up to 4, 12 and 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start10 Jul 2017
- Primary completion3 Jul 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seres Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa von Moltke, MD, Study director, Seres Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183128
- Sponsor's protocol ID
- SERES-012
- Acronym
- ECOSPORIII
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2017
- Last updated
- 27 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bryant JA, Vulic M, Walsh EA, Allen EG Jr, Beauchemin NJ, Chafee ME, Diao L, Fenn K, Ford KA, Hasson BR, Litcofsky KD, Lombardo MJ, Martinez A, O'Brien EJ, Straub TJ, Sykes SM, Marshall LF, Winkler JA, McGovern BH, Ford CB, Wortman JR, Henn MR. The impact of an oral purified microbiome therapeutic on the gastrointestinal microbiome. Nat Med. 2026 Jan;32(1):186-196. doi: 10.1038/s41591-025-04076-w. Epub 2026 Jan 5.
PubMed 41491103Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infect Dis Ther. 2024 Oct;13(10):2105-2121. doi: 10.1007/s40121-024-01007-z. Epub 2024 Jun 28.
PubMed 38941068Garey KW, Jo J, Gonzales-Luna AJ, Lapin B, Deshpande A, Wang E, Hasson B, Pham SV, Huang SP, Reese PR, Wu H, Hohmann E, Feuerstadt P, Oneto C, Berenson CS, Lee C, McGovern B, vonMoltke L. Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2253570. doi: 10.1001/jamanetworkopen.2022.53570.
PubMed 36716031Feuerstadt P, Louie TJ, Lashner B, Wang EEL, Diao L, Bryant JA, Sims M, Kraft CS, Cohen SH, Berenson CS, Korman LY, Ford CB, Litcofsky KD, Lombardo MJ, Wortman JR, Wu H, Aunins JG, McChalicher CWJ, Winkler JA, McGovern BH, Trucksis M, Henn MR, von Moltke L. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. N Engl J Med. 2022 Jan 20;386(3):220-229. doi: 10.1056/NEJMoa2106516.
PubMed 35045228
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03183128
- Acronym / sponsor ID
- ECOSPORIII / SERES-012
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Seres Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Posted 27 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 as determined by a toxin assay 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 12 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 188 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, may be eligible to enroll in the open-label SER-109 extension study (Study SERES-013).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SER-109 | Experimental | Biological: SER-109Received oral dose of SER-109 |
| Placebo | Placebo comparator | Drug: PlaceboReceived matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SER-109SER-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 | Biological | SER-109 |
| PlaceboPlacebo 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(0.9%). | Drug | Placebo |
Primary outcome
Recurrence of CDI up to 8 Weeks
Time frame: Up to Week 8
Recurrence of CDI up to 8 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
1 secondary outcome
Recurrence of CDI up to 4, 12 and 24 Weeks
Time frame: Up to 4, 12 and 24 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41491103Bryant JA, Vulic M, Walsh EA, Allen EG Jr, Beauchemin NJ, Chafee ME, Diao L, Fenn K, Ford KA, Hasson BR, Litcofsky KD, Lombardo MJ, Martinez A, O'Brien EJ, Straub TJ, Sykes SM, Marshall LF, Winkler JA, McGovern BH, Ford CB, Wortman JR, Henn MR. The impact of an oral purified microbiome therapeutic on the gastrointestinal microbiome. Nat Med. 2026 Jan;32(1):186-196. doi: 10.1038/s41591-025-04076-w. Epub 2026 Jan 5.
- Derived from this study: PubMed 38941068Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infect Dis Ther. 2024 Oct;13(10):2105-2121. doi: 10.1007/s40121-024-01007-z. Epub 2024 Jun 28.
- Derived from this study: PubMed 36716031Garey KW, Jo J, Gonzales-Luna AJ, Lapin B, Deshpande A, Wang E, Hasson B, Pham SV, Huang SP, Reese PR, Wu H, Hohmann E, Feuerstadt P, Oneto C, Berenson CS, Lee C, McGovern B, vonMoltke L. Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2253570. doi: 10.1001/jamanetworkopen.2022.53570.
- Derived from this study: PubMed 35045228Feuerstadt P, Louie TJ, Lashner B, Wang EEL, Diao L, Bryant JA, Sims M, Kraft CS, Cohen SH, Berenson CS, Korman LY, Ford CB, Litcofsky KD, Lombardo MJ, Wortman JR, Wu H, Aunins JG, McChalicher CWJ, Winkler JA, McGovern BH, Trucksis M, Henn MR, von Moltke L. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. N Engl J Med. 2022 Jan 20;386(3):220-229. doi: 10.1056/NEJMoa2106516.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa von Moltke, MD study director
Seres Therapeutics, Inc.
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SER-109 in people with Clostridium Difficile Infection, run by Seres Therapeutics, Inc. at 56 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of CDI up to 8 Weeks (time frame: Up to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183128, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.