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Clostridium Difficile InfectionPhase 2NCT02589847

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

A Phase 2 study testing RBX2660 in people with Clostridium Difficile Infection, run by Rebiotix Inc. at 30 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

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. 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?
RBX2660
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
30 sitesin 2 countries
Study dates
Oct 2015to Mar 2019
Phase
Phase 2
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

Who may be able to join

  • ≥ 18 years old.
  • Medical record documentation of recurrent CDI including a positive C. difficile test within 60 days prior to enrollment and either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
  • Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
  • A positive stool test for the presence of C. difficile within 60 days prior to enrollment

Who cannot join

  • A known history of continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
  • Requires continuous antibiotic therapy for a condition other than CDI.
  • Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI < 6 months prior to study enrollment.
  • Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant.
  • Previous treatment with RBX2660.
  • Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
Show all 14Show fewer
  • Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  • History of chronic diarrhea.
  • History of celiac disease.
  • Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
  • Colostomy.
  • Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
  • Life expectancy of < 12 months.
  • Compromised immune system

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States28 sites

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Coral Springs, Florida, 33065

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Flushing, New York, 11355

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Houston, Texas, 77025

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Lafayette, Indiana, 47904

  • Study site

    Lexington, Kentucky, 40506

  • Study site

    Lima, Ohio, 45801

  • Study site

    Maywood, Illinois, 60153

  • Study site

    Miami, Florida, 33101

  • Study site

    North Little Rock, Arkansas, 72117

  • Study site

    Omaha, Nebraska, 68198

  • Study site

    Phoenix, Arizona, 85054

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rochester, New York, 14618

  • Study site

    Sacramento, California, 95817

  • Study site

    Saint Paul, Minnesota, 55130

  • Study site

    Springfield, Virginia, 22150

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Syracuse, New York, 52325

  • Study site

    The Bronx, New York, 10468

  • Study site

    Virginia Beach, Virginia, 23454

Other trials in United States

Canada2 sites

  • Study site

    Hamilton, Ontario, L8N4A6

  • Study site

    Vancouver, British Columbia, V5Z1M9

Other trials in Canada

About this study

Official title: An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).

Read the detailed description

This is a prospective, multicenter, open-label study assessing the efficacy and safety of RBX2660 as an adjunct to antibiotics for the treatment of recurrent CDI. Efficacy of RBX2660, measured by the recurrence-free rate of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment with RBX2660, will be evaluated by comparing the recurrence-free rate observed in the study population to the recurrence-free rate identified from antibiotic-treated historical controls.

Patients who have had either a) at least two recurrences after a primary episode (i.e., at least three episodes) and have completed at least two rounds of standard-of-care oral antibiotics or b) have had at least two episodes of severe CDI resulting in hospitalization may be eligible to participate in the study. Study visits are 1- and 8-weeks after treatment with additional follow-up assessments at 3,6,12, and 24 months post treatment.

Being tested
RBX2660, Standard of Care Antibiotics
Keywords
Clostridium difficile, C diff, CDI, CDAD, Fecal transplant, Fecal Microbiota transplant, diarrhea, FMT, microbiota restoration therapy, microbiota suspension, fecal bacteriotherapy, C diff diarrhea
Medical subject headings
Clostridium Infections, Diarrhea

What participants receive

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

  • RBX2660Biological

    suspension of intestinal microbes

  • Standard of Care AntibioticsDrug

    Also called Antibiotics

    Standard of Care Antibiotics

Study groups in NCT02589847
Study groupRoleWhat they receive
RBX2660 Open-labelExperimentalRBX2660 (microbiota suspension)
Receives: Biological: RBX2660
Historical control antibioticsOtherRetrospective Historical Control with standard of care
Receives: Drug: Standard of Care Antibiotics

What is being measured

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

  1. Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks

    Participants were evaluated 8 weeks after study treatment to assess efficacy of RBX2660. Efficacy was assessed as the absence of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment.

    Measured: 8 weeks after treatment

Secondary outcomes (3)

  1. Quality of Life (SF-36)

    The Short Form - 36 quality of life questionnaire (SF-36) is a tool used to identify changes to quality of life following study treatment. It consists of a series of 36 questions relating to Mental and Physical health, summarized by a Physical Component Score (PCS) and Mental Component Score (MCS), respectively. Several sub-scales exist for each of the larger components; PCS includes PF, RP, BP, and GH while, MCS includes VT, SF, RE, and MH [All abbreviations are defined in table]. All Sub-Scale and Component Scores were calculated using Quality Metric Health Outcomes Scoring Software v4.5. The range of all scores is normalized from 0 (worst) to 100 (best). The data is presented for mean scores at baseline and 8-weeks post-treatment.

    Measured: Baseline

  2. Quality of Life (SF-36)

    The Short Form - 36 quality of life questionnaire (SF-36) is a tool used to identify changes to quality of life following study treatment. It consists of a series of 36 questions relating to Mental and Physical health, summarized by a Physical Component Score (PCS) and Mental Component Score (MCS), respectively. Several sub-scales exist for each of the larger components; PCS includes PF, RP, BP, and GH while, MCS includes VT, SF, RE, and MH [All abbreviations are defined in table]. All Sub-Scale and Component Scores were calculated using Quality Metric Health Outcomes Scoring Software v4.5. The range of all scores is normalized from 0 (worst) to 100 (best). The data is presented for mean scores at baseline and 8-weeks post-treatment.

    Measured: 8-Weeks

  3. Number of Participants With Major Complications of rCDI From Baseline Through 24 Months

    Major complications of rCDI, defined as death, septic shock, toxic megacolon, colonic perforation, emergency colectomy, or ICU admission) were collected and reported as a safety-related endpoint.

    Measured: 24 months

Timeline

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

  1. First posted28 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJun 2017
  4. Study completionMar 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02589847
Sponsor's protocol ID
2015-01
Status last verified
Feb 2021
First submitted
26 Oct 2015
Last updated
26 Mar 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chopra T, Van Handel D, Baggott B, Orenstein R, Reveles K, Guthmueller B, Srivastava S, Khanna S. Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies. Infect Dis Ther. 2026 Aug;15(8):2071-2086. doi: 10.1007/s40121-026-01374-9. Epub 2026 Jun 12.

    PubMed 42286373

  • Lee C, Feuerstadt P, Louie T, Bancke L, Guthmueller B, Harvey A, Hoeyer F, Orenstein R, Dubberke ER, Khanna S. Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. Ther Adv Gastroenterol. 2025 Nov 12;18:17562848251395566. doi: 10.1177/17562848251395566. eCollection 2025.

    PubMed 41245385

  • Reveles KR, Gonzales-Luna AJ, Golan Y, Alonso CD, Guthmueller B, Tan X, Bidell MR, Pokhilko V, Crawford CV, Skinner AM. Efficacy of Fecal Microbiota, Live-jslm (REBYOTA(R)), Among Patients Exposed to Non-Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Study. Open Forum Infect Dis. 2024 Jun 17;11(7):ofae341. doi: 10.1093/ofid/ofae341. eCollection 2024 Jul.

    PubMed 39006315

  • Orenstein R, Dubberke ER, Khanna S, Lee CH, Yoho D, Johnson S, Hecht G, DuPont HL, Gerding DN, Blount KF, Mische S, Harvey A. Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial. BMC Infect Dis. 2022 Mar 12;22(1):245. doi: 10.1186/s12879-022-07256-y.

    PubMed 35279084

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RBX2660 in people with Clostridium Difficile Infection, run by Rebiotix Inc. at 30 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?

The sponsor lists 4 inclusion and 14 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 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 May 2020). 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?

Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks (time frame: 8 weeks after treatment). 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 NCT02589847, which also lists 4 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 26 Mar 2021.

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