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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02437487
Other study ID # SERES-004
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2015
Est. completion date October 2016

Study information

Verified date June 2018
Source Seres Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date October 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Anne Arundel Health System Research Institute Annapolis Maryland
United States Emory University Atlanta Georgia
United States ZASA Clinical Research Atlantis Florida
United States Johns Hopkins Bayview Medical Baltimore Maryland
United States Beth Israel Deaconess Med Cntr Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Mercury Street Medical Group Butte Montana
United States Mayo Clinic Chatfield Minnesota
United States Metropolitan Gastroenterolgy Group Pc Chevy Chase Maryland
United States University of Cincinnati College of Medicine Cincinnati Ohio
United States Remington-Davis, Inc. Columbus Ohio
United States Omega Research Consultants LLC DeBary Florida
United States Englewood Hospital and Medical Center Englewood Cliffs New Jersey
United States University of Texas School of Public Health Houston Texas
United States Idaho Falls Infection Diseases Idaho Falls Idaho
United States Borland-Groover Clinic Jacksonville Florida
United States Regional Infectious Diseases-Infusion Center Inc Lima Ohio
United States Medical Associates of Central Virginia Lynchburg Virginia
United States Gastroenterology Group of Naples Naples Florida
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Mount Sinai Hospital New York New York
United States North County Gastroenterology Oceanside California
United States Drexel University/Hahnemann University Hospital Philadelphia Pennsylvania
United States Advanced Medical Research Center Port Orange Florida
United States Brown Alpert Medical School Providence Rhode Island
United States University of Rochester Medical Center Rochester New York
United States William Beaumont Hospital Royal Oak Michigan
United States University Of California Davis Sacramento California
United States Sundance Clinical Research Saint Louis Missouri
United States Ventura Clinical Trials Ventura California

Sponsors (2)

Lead Sponsor Collaborator
Seres Therapeutics, Inc. INC Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With CDI Recurrence 8 weeks after treatment.
Secondary Time to Recurrence of CDI Kaplan-Meier estimate of median number of days to recurrence Recurrence of CDI up to 24 weeks after treatment.
Secondary Number of Subjects With CDI Recurrence 4 Weeks
Secondary Number of Subjects With CDI Recurrence 12 Weeks
Secondary Number of Subjects With CDI Recurrence 24 Weeks
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