ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection

NCT03183128 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: SERES-012
• Study Type: interventional
• Target: 182
• Locations: 2 countries
• Sites: 56

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 as determined by a toxin assay in adults up to 8 weeks after initiation of treatment.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Week 8

Secondary Outcomes (1)

• Recurrence of CDI up to 4, 12 and 24 Weeks

  Up to 4, 12 and 24 weeks after treatment

Study Arms (2)

SER-109

EXPERIMENTAL

Received oral dose of SER-109

Biological: SER-109

Placebo

PLACEBO COMPARATOR

Received matching placebo

Drug: Placebo

Interventions

SER-109 BIOLOGICAL

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

SER-109

Placebo DRUG

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%).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seres Therapeutics, Inc.: lead

Study Sites (56)

(Investigator site)

North Little Rock, Arkansas, 72117, United States

Location

(Investigator site)

Mather, California, 95655, United States

Location

(Investigator site)

Mountain View, California, 94040, United States

Location

(Investigator site)

Northridge, California, 91324, United States

Location

(Investigator site)

Sacramento, California, 95817, United States

Location

(Investigator site)

Simi Valley, California, 93065, United States

Location

(Investigator site)

Upland, California, 91786, United States

Location

(Investigator site)

Hamden, Connecticut, 06518, United States

Location

(Investigator site)

Washington D.C., District of Columbia, 20007, United States

Location

(Investigator site)

Jacksonville, Florida, 32256, United States

Location

(Investigator site)

Miami, Florida, 33015, United States

Location

(Investigator site)

Miami, Florida, 33155, United States

Location

(Investigator site)

Pembroke Pines, Florida, 33024, United States

Location

(Investigator site)

Pembroke Pines, Florida, 33026, United States

Location

(Investigator site)

Athens, Georgia, 30607, United States

Location

(Investigator site)

Atlanta, Georgia, 30322, United States

Location

(Investigator site)

Marietta, Georgia, 30060, United States

Location

(Investigator site)

Riverdale, Georgia, 30274, United States

Location

(Investigator site)

Sandy Springs, Georgia, 30342, United States

Location

(Investigator site)

Idaho Falls, Idaho, 83404, United States

Location

(Investigator site)

Springfield, Illinois, 62703, United States

Location

(Investigator site)

Evansville, Indiana, 47714, United States

Location

(Investigator site)

Jeffersonville, Indiana, 47130, United States

Location

(Investigator site)

Iowa City, Iowa, 52242, United States

Location

(Investigator site)

Kansas City, Kansas, 66160, United States

Location

(Investigator site)

New Orleans, Louisiana, 70121, United States

Location

(Investigator site)

Annapolis, Maryland, 21401, United States

Location

(Investigator site)

Chevy Chase, Maryland, 20814, United States

Location

(Investigator site)

Boston, Massachusetts, 02144, United States

Location

(Investigator site)

Worcester, Massachusetts, 01655, United States

Location

(Investigator site)

Detroit, Michigan, 48202, United States

Location

(Investigator site)

Royal Oak, Michigan, 48073, United States

Location

(Investigator site)

St Louis, Missouri, 63141, United States

Location

(Investigator site)

Butte, Montana, 59701, United States

Location

(Investigator site)

Las Vegas, Nevada, 89119, United States

Location

(Investigator site)

Buffalo, New York, 14215, United States

Location

(Investigator site)

Greenville, North Carolina, 27834, United States

Location

(Investigator site)

Kinston, North Carolina, 28501, United States

Location

(Investigator site)

Raleigh, North Carolina, 27607, United States

Location

(Investigator site)

Centerville, Ohio, 45459, United States

Location

(Investigator site)

Cleveland, Ohio, 44195, United States

Location

(Investigator site)

Columbus, Ohio, 43215, United States

Location

(Investigator site)

Pittsburgh, Pennsylvania, 15213, United States

Location

(Investigator site)

Sayre, Pennsylvania, 18840, United States

Location

(Investigator site)

Houston, Texas, 77098, United States

Location

(Investigator site)

San Antonio, Texas, 78234, United States

Location

(Investigator site)

Southlake, Texas, 76092, United States

Location

(Investigator site)

Bountiful, Utah, 84010, United States

Location

(Investigator site)

Riverton, Utah, 84065, United States

Location

(Investigator site)

Charlottesville, Virginia, 22908, United States

Location

(Investigator site)

Reston, Virginia, 20191, United States

Location

(Investigator site)

Calgary, Alberta, T2N 2T9, Canada

Location

(Investigator site)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

(Investigator site)

Victoria, British Columbia, V8R 1J8, Canada

Location

(Investigator site)

London, Ontario, N6A 4V2, Canada

Location

(Investigator site)

Chicoutimi, Quebec, G7H 7Y8, Canada

Location

Related Publications (4)

• 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.

  PMID: 41491103 DERIVED

• Kraft 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.

  PMID: 38941068 DERIVED

• Garey 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.

  PMID: 36716031 DERIVED

• Feuerstadt 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.

  PMID: 35045228 DERIVED

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Lisa von Moltke, MD, Chief Medical Officer
• Organization: Seres Therapeutics

clinicalstudies@serestherapeutics.com

617-945-9626

Study Officials

• Lisa von Moltke, MD

  Seres Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 9, 2017
• Study Start: July 10, 2017
• Primary Completion: July 3, 2020
• Study Completion: September 29, 2020
• Last Updated: April 27, 2023
• Results First Posted: April 27, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); US (51)