SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
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|ClinicalTrials.gov Identifier: NCT02830542|
Recruitment Status : Unknown
Verified March 2018 by Seres Therapeutics, Inc..
Recruitment status was: Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: SER-262 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of SER-262 in Adults With Primary Clostridium Difficile Infection (CDI) to Prevent Recurrence|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||October 2018|
SER-262 [Single dose: 10(4), 10(5), 10(6), 10(7) or 10(8) SCFUs; Multiple dose 10(6), 10(7), or 10(8) SCFUs]
SER-262 is a rationally designed, multi-strain Ecobiotic® microbiome therapeutic produced synthetically by in vitro fermentation. It is a consortium of anaerobic, commensal bacteria in spore form, encapsulated for oral administration.
Other Name: Cultivated Eubacterial Spore Suspension, Encapsulated
Placebo Comparator: Placebo
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.
- Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings [ Time Frame: Up to 24 weeks after treatment ]
- Relative risk of recurrence based on the proportion of subjects experiencing CDI recurrence in each SER-262 cohort compared to placebo up to 8 weeks after treatment [ Time Frame: Up to 8 weeks after treatment ]
- Time to recurrence of CDI [ Time Frame: Up to 24 weeks after treatment ]
- Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment [ Time Frame: Up to 4, 12, and 24 weeks after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830542
|Study Director:||Michele Trucksis, PhD, MD||Seres Therapeutics|