Clostridium Difficile InfectionPhase 1NCT02830542
SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
A Phase 1 study testing SER-262 in people with Clostridium Difficile Infection, run by Seres Therapeutics, Inc. at 22 sites in United States.
Trial summary
The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- SER-262
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 22 sitesUnited States
- Study dates
- Aug 2016to Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
- Male or female subjects ≥ 18 years.
- A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic treatment (including start and stop dates), and response to treatment
Who cannot join
- Females 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 12 months.
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
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- Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Patients discharged from an intensive care unit before Day 1 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).
- Absolute neutrophil count < 500 cells/mm3
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Anne Arundel Health System Research Institute
Annapolis, Maryland, 21401
North Alabama Research Center, LLC
Athens, Alabama, 35749
Emory University Hospital
Atlanta, Georgia, 30322
Dr. Hansen Internal Medicine
Bountiful, Utah, 84010
Mercury St. Medical Group
Butte, Montana, 59701
Remington Davis
Columbus, Ohio, 43215
Henry Ford Health System
Detroit, Michigan, 48202
Lalla-Reddy Medical Corporation
Fountain Valley, California, 92708
Snake River Research
Idaho Falls, Idaho, 83404
eStudySite
La Mesa, California, 91942
Regional Infectious Diseases & Infusion Center
Lima, Ohio, 45801
Infectious Disease Associates of Central Virginia
Lynchburg, Virginia, 24501
San Marcus Research Clinic, Inc.
Miami, Florida, 33015
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Quality Clinical Research
Omaha, Nebraska, 68114
Omega Research Consultants
Orlando, Florida, 32810
Mayo Clinic
Rochester, Minnesota, 55902
University of Rochester Medical Center
Rochester, New York, 14642
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Baylor Scott & White Research Institute
Temple, Texas, 76508
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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
The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).
Read the detailed description
SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1.
- Conditions
- Clostridium Difficile Infection
- Being tested
- SER-262, Placebo
- Keywords
- Clostridium difficile, C Diff, CDI
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SER-262Drug
Also called Cultivated Eubacterial Spore Suspension, Encapsulated
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SER-262 | Experimental | 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] Receives: Drug: SER-262 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings
Measured: 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
Measured: Up to 8 weeks after treatment
Secondary outcomes (2)
Time to recurrence of CDI
Measured: Up to 24 weeks after treatment
Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment
Measured: Up to 4, 12, and 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seres Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharm-Olam International
- Responsible party
- Sponsor
- Investigators
- Michele Trucksis, PhD, MD, Study director, Seres Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830542
- Sponsor's protocol ID
- SER-262-001
- Status last verified
- Feb 2023
- First submitted
- 6 Jul 2016
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02830542
- Acronym / sponsor ID
- SER-262-001
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile, C Diff, CDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Seres Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pharm-Olam International
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).
Detailed description
SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SER-262 | Experimental | Drug: SER-262SER-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] |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
- Male or female subjects ≥ 18 years.
- A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic treatment (including start and stop dates), and response to treatment
Key exclusion criteria (9 listed)
- Females 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 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SER-262Also: Cultivated Eubacterial Spore Suspension, EncapsulatedSER-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. | Drug | SER-262 |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Trucksis, PhD, MD study director
Seres Therapeutics
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SER-262 in people with Clostridium Difficile Infection, run by Seres Therapeutics, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.