Clostridioides Difficile InfectionPhase 3NCT03183141

ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection

A Phase 3 study testing SER-109 in people with Clostridioides Difficile Infection, run by Seres Therapeutics, Inc. at 107 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks after… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Clostridioides Difficile Infection
What is being tested?: SER-109
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 263 participants
Where: 107 sitesin 2 countries
Study dates: 23 Oct 2017to 29 Apr 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Cohort 1 Main Inclusion Criteria:

Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of a treatment regimen of SER-109 or placebo
Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject, or their legally authorized representative, must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
The CDI recurrence in Study SERES-012 must have met the protocol definition of ≥ 3 unformed stools per day over 2 consecutive days, a positive C. difficile stool toxin assay, and the requirement of CDI SOC antibiotic therapy, and an adequate clinical response following antibiotic therapy (<3 unformed stools in 24 hours for 2 or more consecutive days).

Cohort 1 Main Exclusion Criteria:

Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
Known or suspected toxic megacolon and/or known small bowel ileus.
Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
Absolute neutrophil count of <500 cells/mm^3.
Major gastrointestinal surgery (e.g. 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 (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
Any history of fecal microbiota transplantation (FMT) in the past 3 months.

Cohort 2 Main Inclusion Criteria:

Subjects 18 years of age or older who had one or more CDI recurrence (as confirmed by a C. difficile stool toxin or PCR test) and have responded to a course of antibiotic treatment.
Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject, or their legally authorized representative, must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.

Cohort 2 Main Exclusion Criteria:

(all Cohort 1 exclusion criteria [#1-8 above] plus the below addition criterion)

Previously enrolled in a Seres Therapeutics clinical study. An exception is made for subjects who screened in SERES-012 who did not receive SER-109 and did not previously roll-over to SERES-013.

Trial locations and contacts

107 sites in 2 countries.

Country

City, postcode or hospital

107 sites in 2 countries

United States97 sites

(Investigator site)
Akron, Ohio, 44304
(Investigator site)
Annapolis, Maryland, 21401
(Investigator site)
Athens, Georgia, 30607
(Investigator site)
Atlanta, Georgia, 30322
(Investigator site)
Boise, Idaho, 83706
(Investigator site)
Boston, Massachusetts, 02114
(Investigator site)
Buffalo, New York, 14215
(Investigator site)
Butte, Montana, 59701
(Investigator site)
Camp Hill, Pennsylvania, 17011
(Investigator site)
Centerville, Ohio, 45459
(Investigator site)
Charlotte, North Carolina, 28210
(Investigator site)
Chesterfield, Michigan, 48047
(Investigator site)
Chesterfield, Missouri, 63017
(Investigator site)
Chevy Chase, Maryland, 20815
(Investigator site)
Chicago, Illinois, 60637
(Investigator site)
Cincinnati, Ohio, 45219
(Investigator site)
Clearwater, Florida, 33756
(Investigator site)
Clearwater, Florida, 33761
(Investigator site)
Cleveland, Ohio, 44195
(Investigator site)
Cypress, Texas, 77429
(Investigator site)
Decatur, Georgia, 30033
(Investigator site)
DeLand, Florida, 32720
(Investigator site)
Detroit, Michigan, 48202
(Investigator site)
Dothan, Alabama, 36305
(Investigator site)
Evansville, Indiana, 47714
(Investigator site)
Flint, Michigan, 48504
(Investigator site)
Framingham, Massachusetts, 01702
(Investigator site)
Garland, Texas, 75044
(Investigator site)
Glen Burnie, Maryland, 21061
(Investigator site)
Greenville, North Carolina, 27834
(Investigator site)
Harrisburg, Pennsylvania, 17110
(Investigator site)
Hialeah, Florida, 33016
(Investigator site)
Homestead, Florida, 33032
(Investigator site)
Houston, Texas, 77024
(Investigator site)
Houston, Texas, 77025
(Investigator site)
Houston, Texas, 77057
(Investigator site)
Houston, Texas, 77084
(Investigator site)
Idaho Falls, Idaho, 83404
(Investigator site)
Iowa City, Iowa, 52242
(Investigator site)
Jacksonville, Florida, 32256
(Investigator site)
Jacksonville, North Carolina, 28546
(Investigator site)
Kansas City, Kansas, 66160
(Investigator site)
Kinston, North Carolina, 28501
(Investigator site)
Marietta, Georgia, 30060
(Investigator site)
Mather, California, 95655
(Investigator site)
McKinney, Texas, 75071
(Investigator site)
Mentor, Ohio, 44060
(Investigator site)
Miami, Florida, 33125
(Investigator site)
Miami, Florida, 33126
(Investigator site)
Miami, Florida, 33144
(Investigator site)
Miami, Florida, 33155
(Investigator site)
Miami, Florida, 33165
(Investigator site)
Miami, Florida, 33175
(Investigator site)
Miami Lakes, Florida, 33014
(Investigator site)
Milwaukee, Wisconsin, 53215
(Investigator site)
Morristown, New Jersey, 07960
(Investigator site)
Morrow, Georgia, 30260
(Investigator site)
Mountain View, California, 94040
(Investigator site)
Murrieta, California, 92563
(Investigator site)
Naples, Florida, 34102
(Investigator site)
Neptune City, New Jersey, 07754
(Investigator site)
New Orleans, Louisiana, 70121
(Investigator site)
New York, New York, 10279
(Investigator site)
North Dartmouth, Massachusetts, 02747
(Investigator site)
Northridge, California, 91324
(Investigator site)
Oak Lawn, Illinois, 60453
(Investigator site)
Ogden, Utah, 84403
(Investigator site)
Orlando, Florida, 32819
(Investigator site)
Pasadena, Texas, 77505
(Investigator site)
Pembroke Pines, Florida, 33024
(Investigator site)
Pembroke Pines, Florida, 33026
(Investigator site)
Pittsburgh, Pennsylvania, 15213
(Investigator site)
Port Orange, Florida, 32127
(Investigator site)
Providence, Rhode Island, 02905
(Investigator site)
Riverton, Utah, 84065
(Investigator site)
Rochester, Minnesota, 55905
(Investigator site)
Royal Oak, Michigan, 48073
(Investigator site)
Sacramento, California, 95817
(Investigator site)
Salt Lake City, Utah, 84114
(Investigator site)
San Antonio, Texas, 78229
(Investigator site)
San Bernardino, California, 92408
(Investigator site)
San Diego, California, 92123
(Investigator site)
San Dimas, California, 91773
(Investigator site)
Sayre, Pennsylvania, 18840
(Investigator site)
Simi Valley, California, 93065
(Investigator site)
Southlake, Texas, 76092
(Investigator site)
Spokane, Washington, 99202
(Investigator site)
Spring, Texas, 77379
(Investigator site)
Springfield, Illinois, 62703
(Investigator site)
Sun City West, Arizona, 85375
(Investigator site)
Tacoma, Washington, 98405
(Investigator site)
Thousand Oaks, California, 91360
(Investigator site)
Toledo, Ohio, 43617
(Investigator site)
Union City, Tennessee, 38261
(Investigator site)
Weymouth, Massachusetts, 02190
(Investigator site)
Worcester, Massachusetts, 01655
(Investigator site)
Wyoming, Michigan, 49519

Other trials in United States

Canada10 sites

(Investigator site)
Calgary, Alberta, T2N 2T9
(Investigator site)
Chicoutimi, Quebec, G7H 7Y8
(Investigator site)
London, Ontario, N6A 4V2
(Investigator site)
North Bay, Ontario, P1B 2H3
(Investigator site)
Québec, Quebec, G2J 0C4
(Investigator site)
Sainte-Foy, Quebec, G1W 4R4
(Investigator site)
Scarborough Village, Ontario, M1P 2T7
(Investigator site)
St. John's, Newfoundland and Labrador, A1B 3V6
(Investigator site)
Vancouver, British Columbia, V5Z 1M9
(Investigator site)
Victoria, British Columbia, V8R 1J8

Other trials in Canada

About this study

Official title: ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI)

Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years of age or older with at least a first recurrence of CDI.

Read the detailed description

Cohort 1 is an open-label extension of study SERES-012. Subjects who had a CDI recurrence in study SERES-012 within 8 weeks of receipt of study drug, have responded to a course of standard of care (SOC) antibiotic treatment, will receive an oral dose of SER-109. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days.

Approximately 30 eligible subjects with recurrent CDI disease from study SERES-012 are expected to enroll. Screening for this study will begin at the Recurrence Visit of Study SERES-012.

Cohort 2 is an open-label program for subjects who were not part of SERES-012. Subjects 18 years of age or older who had one or more CDI recurrence and have responded to a course of antibiotic treatment will receive an oral dose of SER-109. The CDI recurrence must be confirmed by a positive C. difficile stool toxin or polymerase chain reaction (PCR) assay to confirm eligibility. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days.

Approximately 200 eligible subjects with recurrent CDI disease are expected to enroll.

Conditions: Clostridioides Difficile Infection
Being tested: SER-109
Keywords: Clostridioides infection, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Gram-Positive Bacterial Infections, Communicable Diseases
Medical subject headings: Clostridium Infections, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Gram-Positive Bacterial Infections, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SER-109Biological
Also called Firmicutes spores
SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores

Study groups in NCT03183141
Study group	Role	What they receive
SER-109	Experimental	Received oral dose of SER-109 Receives: Biological: SER-109

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1: Recurrence of CDI and Sustained Clinical Response
Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Measured: Up to Week 8
Cohort 2: Recurrence of CDI and Sustained Clinical Response
Cohort 2: Recurrence of CDI up to 8 and 12 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 and 12 Weeks after treatment.
Measured: Up to Weeks 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 201729 Apr 2022

First posted9 Jun 2017
Study start23 Oct 2017
Primary completion29 Apr 2022
Study completion29 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Clostridioides 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03183141
Sponsor's protocol ID: SERES-013
Status last verified: Apr 2023
First submitted: 8 Jun 2017
Last updated: 10 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No
Expanded access: Available

Publications

Chua HC, Pham S, Lombardi DA, Hot E, Mody L. Patient Satisfaction Scale Following a Laxative for Antibiotic Washout Prior to Oral Microbiome Therapy. Adv Ther. 2025 Jan;42(1):490-499. doi: 10.1007/s12325-024-03065-8. Epub 2024 Nov 28.
PubMed 39607629
Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infect Dis Ther. 2024 Oct;13(10):2105-2121. doi: 10.1007/s40121-024-01007-z. Epub 2024 Jun 28.
PubMed 38941068
Sims MD, Khanna S, Feuerstadt P, Louie TJ, Kelly CR, Huang ES, Hohmann EL, Wang EEL, Oneto C, Cohen SH, Berenson CS, Korman L, Lee C, Lashner B, Kraft CS, Ramesh M, Silverman M, Pardi DS, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L; ECOSPOR IV Investigators. Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255758. doi: 10.1001/jamanetworkopen.2022.55758.
PubMed 36780159

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Clostridium Difficile Infection
RecruitingPhase 1/2
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Clostridioides Difficile Infection, Recurrent Infection
RecruitingObservational study
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Clostridium Difficile Infection, Clostridioides Difficile Infection
RecruitingPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence
Active, not recruitingObservational study
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Dysbiosis, Clostridium Difficile

All Clostridioides Difficile Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI)
ClinicalTrials.gov ID: NCT03183141
Acronym / sponsor ID: SERES-013
Conditions: Clostridioides Difficile Infection
Keywords: Clostridioides infection, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases, Gram-Positive Bacterial Infections, Communicable Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: Seres Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 23 Oct 2017 (actual)
Primary completion: 29 Apr 2022 (actual)
Study completion: 29 Apr 2022 (actual)
First posted: 9 Jun 2017 (actual)
Results: Posted 31 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 30 eligible subjects with recurrent CDI disease from study SERES-012 are expected to enroll. Screening for this study will begin at the Recurrence Visit of Study SERES-012.

Approximately 200 eligible subjects with recurrent CDI disease are expected to enroll.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SER-109	Experimental	Biological: SER-109Received oral dose of SER-109

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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-109Also: Firmicutes sporesSER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores	Biological	SER-109

Primary outcome

Cohort 1: Recurrence of CDI and Sustained Clinical Response
Time frame: Up to Week 8
Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Cohort 2: Recurrence of CDI and Sustained Clinical Response
Time frame: Up to Weeks 8 and 12
Cohort 2: Recurrence of CDI up to 8 and 12 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 and 12 Weeks after treatment.

Results and safety

Results posted to the registry on 31 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	29	27
Cohort 2	234	222

Primary outcome: Cohort 1: Recurrence of CDI and Sustained Clinical Response

Time frame: Up to Week 8. Count of participants. Unit: Participants

Measure	Cohort 1 n = 29
Number of participants with CDI recurrence	4
Number of participants with sustained response	25

Population analysed: The analysis population consisted of all enrolled participants.

Primary outcome: Cohort 2: Recurrence of CDI and Sustained Clinical Response

Time frame: Up to Weeks 8 and 12. Count of participants. Unit: Participants

Measure	Cohort 2 n = 234
Week 8: Number of participants with CDI recurrence	19
Week 8: Number of participants with sustained clinical response	215
Week 12: Number of participants with CDI recurrence	23
Week 12: Number of participants with sustained clinical response	211

Population analysed: The analysis population consisted of all enrolled participants.

Adverse events

Time frame: 24 weeks follow-up starting Day 1 post-dosing with SER-109. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	1 of 29 (3.4%)	14 of 29 (48.3%)	0 of 29
Cohort 2	32 of 234 (13.7%)	68 of 234 (29.1%)	8 of 234

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39607629Chua HC, Pham S, Lombardi DA, Hot E, Mody L. Patient Satisfaction Scale Following a Laxative for Antibiotic Washout Prior to Oral Microbiome Therapy. Adv Ther. 2025 Jan;42(1):490-499. doi: 10.1007/s12325-024-03065-8. Epub 2024 Nov 28.
Derived from this study: PubMed 38941068Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infect Dis Ther. 2024 Oct;13(10):2105-2121. doi: 10.1007/s40121-024-01007-z. Epub 2024 Jun 28.
Derived from this study: PubMed 36780159Sims MD, Khanna S, Feuerstadt P, Louie TJ, Kelly CR, Huang ES, Hohmann EL, Wang EEL, Oneto C, Cohen SH, Berenson CS, Korman L, Lee C, Lashner B, Kraft CS, Ramesh M, Silverman M, Pardi DS, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L; ECOSPOR IV Investigators. Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255758. doi: 10.1001/jamanetworkopen.2022.55758.
Individual participant dataSharing planned: No

Related trials for Clostridioides Difficile Infection

Not yet recruitingPhase 1
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Clostridium Difficile Infection
RecruitingPhase 1/2
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Clostridioides Difficile Infection, Recurrent Infection
RecruitingObservational study
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Clostridium Difficile Infection, Clostridioides Difficile Infection
RecruitingPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence
Active, not recruitingObservational study
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Dysbiosis, Clostridium Difficile

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.

Elaine Wang, MD study director

Seres Therapeutics, Inc.

107 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SER-109 in people with Clostridioides Difficile Infection, run by Seres Therapeutics, Inc. at 107 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cohort 1: Recurrence of CDI and Sustained Clinical Response (time frame: Up to Week 8). 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?

On the ClinicalTrials.gov record for NCT03183141, which also lists 3 linked publications.

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 10 Apr 2023.