Clinical Trials Logo
  1. Home
  2. Clostridium Difficile
  3. NCT02437487

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

Clostridium Difficile Clinical Trial

Official title:
ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02437487
Study type Interventional
Source Seres Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date May 2015
Completion date October 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT02896244 - AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Recruiting NCT01973465 - Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis N/A
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Completed NCT01066221 - Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile N/A
Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Completed NCT02563106 - A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI Phase 2
Completed NCT02207140 - Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly Phase 0
Completed NCT02857582 - Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile Phase 2
Not yet recruiting NCT01942447 - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis N/A
Active, not recruiting NCT01703494 - Fecal Transplant for Relapsing C. Difficile Infection Phase 2
Completed NCT01813500 - Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients N/A
Completed NCT01087892 - Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection N/A
Suspended NCT00591357 - Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy Phase 4
Recruiting NCT00377078 - Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile. N/A
Completed NCT02254967 - A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population Phase 4
Terminated NCT01775397 - A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System Phase 4
Terminated NCT03617172 - PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol Phase 2
Recruiting NCT05622721 - REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Completed NCT02127814 - Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile N/A