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

PHASE2CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

July 31, 2016

Study Completion Date

October 31, 2016

Conditions
Clostridium Difficile
Interventions
DRUG

SER-109

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

DRUG

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.

Trial Locations (30)

10029

Mount Sinai Hospital, New York

14642

University of Rochester Medical Center, Rochester

19107

Drexel University/Hahnemann University Hospital, Philadelphia

20815

Metropolitan Gastroenterolgy Group Pc, Chevy Chase

21410

Anne Arundel Health System Research Institute, Annapolis

24501

Medical Associates of Central Virginia, Lynchburg

30322

Emory University, Atlanta

32127

Advanced Medical Research Center, Port Orange

32713

Omega Research Consultants LLC, DeBary

33256

Borland-Groover Clinic, Jacksonville

33462

ZASA Clinical Research, Atlantis

34102

Gastroenterology Group of Naples, Naples

43215

Remington-Davis, Inc., Columbus

45267

University of Cincinnati College of Medicine, Cincinnati

45801

Regional Infectious Diseases-Infusion Center Inc, Lima

48073

William Beaumont Hospital, Royal Oak

55905

Mayo Clinic, Chatfield

59701

Mercury Street Medical Group, Butte

63141

Sundance Clinical Research, St Louis

70121

Ochsner Clinic Foundation, New Orleans

77030

University of Texas School of Public Health, Houston

83404

Idaho Falls Infection Diseases, Idaho Falls

92056

North County Gastroenterology, Oceanside

93003

Ventura Clinical Trials, Ventura

95817

University Of California Davis, Sacramento

21224-2780

Johns Hopkins Bayview Medical, Baltimore

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Med Cntr, Boston

07632-2514

Englewood Hospital and Medical Center, Englewood Cliffs

02904

Brown Alpert Medical School, Providence

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Seres Therapeutics, Inc.

INDUSTRY