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

NCT02437487 | Completed Phase 2 Results DMC

• 1 other identifier: SERES-004
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 30

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.

Conditions

Clostridium Difficile

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With CDI Recurrence

  8 weeks after treatment.

Secondary Outcomes (4)

• Time to Recurrence of CDI

  Recurrence of CDI up to 24 weeks after treatment.

• Number of Subjects With CDI Recurrence

  4 Weeks

• Number of Subjects With CDI Recurrence

  12 Weeks

• Number of Subjects With CDI Recurrence

  24 Weeks

Study Arms (2)

SER-109

EXPERIMENTAL

SER 109 (1 × 108 SporQs)

Drug: SER-109

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SER-109 DRUG

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

Also known as: Purified Eubacterial Spores, Encapsulated

SER-109

Placebo DRUG

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.

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, 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.
• Male or female patients ≥ 18 years.
• ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode with documentation of ≥ 2 episodes.

You may not qualify if:

• Female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
• Known or suspected toxic megacolon and/or known small bowel ileus.
• Active irritable bowel syndrome with diarrhea within the previous 12 months.
• 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.
• 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.
• 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.
• Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).

Sponsors & Collaborators

• Seres Therapeutics, Inc.: lead
• Syneos Health: collaborator

Study Sites (30)

North County Gastroenterology

Oceanside, California, 92056, United States

Location

University Of California Davis

Sacramento, California, 95817, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

ZASA Clinical Research

Atlantis, Florida, 33462, United States

Location

Omega Research Consultants LLC

DeBary, Florida, 32713, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 33256, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Idaho Falls Infection Diseases

Idaho Falls, Idaho, 83404, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Anne Arundel Health System Research Institute

Annapolis, Maryland, 21410, United States

Location

Johns Hopkins Bayview Medical

Baltimore, Maryland, 21224-2780, United States

Location

Metropolitan Gastroenterolgy Group Pc

Chevy Chase, Maryland, 20815, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Med Cntr

Boston, Massachusetts, 02215, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic

Chatfield, Minnesota, 55905, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

Englewood Hospital and Medical Center

Englewood Cliffs, New Jersey, 07632-2514, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

Regional Infectious Diseases-Infusion Center Inc

Lima, Ohio, 45801, United States

Location

Drexel University/Hahnemann University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Brown Alpert Medical School

Providence, Rhode Island, 02904, United States

Location

University of Texas School of Public Health

Houston, Texas, 77030, United States

Location

Medical Associates of Central Virginia

Lynchburg, Virginia, 24501, United States

Location

Related Publications (2)

• 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

• McGovern BH, Ford CB, Henn MR, Pardi DS, Khanna S, Hohmann EL, O'Brien EJ, Desjardins CA, Bernardo P, Wortman JR, Lombardo MJ, Litcofsky KD, Winkler JA, McChalicher CWJ, Li SS, Tomlinson AD, Nandakumar M, Cook DN, Pomerantz RJ, Aunins JG, Trucksis M. SER-109, an Investigational Microbiome Drug to Reduce Recurrence After Clostridioides difficile Infection: Lessons Learned From a Phase 2 Trial. Clin Infect Dis. 2021 Jun 15;72(12):2132-2140. doi: 10.1093/cid/ciaa387.

  PMID: 32255488 DERIVED

Results Point of Contact

• Title: Dr. Michele Trucksis, Chief Medical Officer
• Organization: Seres Therapeutics

mtrucksis@serestherapeutics.com

(617) 945-9626

Study Officials

• Michele Trucksis, Phd, MD

  Seres Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 7, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-06

Locations

US (30)