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Recurrent Clostridium Difficile InfectionPhase 2PUNCH CDNCT01925417

Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea

A Phase 2 study testing RBX2660 (microbiota suspension) in people with Recurrent Clostridium Difficile Infection, run by Rebiotix Inc. at 13 sites in United States.

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 assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RBX2660 (microbiota suspension)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
13 sitesUnited States
Study dates
Aug 2013to Jul 2014
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
  • Medical record documentation of CDAD either: a) at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or b) have had at least two episodes of severe CDAD resulting in hospitalization.
  • Willing and able to have an enema(s).
  • Already taking or will start a course of oral antibiotics for CDAD symptoms for 10-14 days, including at least seven days of oral vancomycin.
  • Willing and able to complete the required subject diary.

Who cannot join

  • Continued (uncontrolled) CDAD after completing a 10-14 day course of oral antibiotics.
  • Requires antibiotic therapy for a condition other than CDAD.
  • Previous fecal transplant prior to study enrollment.
  • History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  • History of irritable bowel syndrome (IBS).
  • History of chronic diarrhea.
Show all 20Show fewer
  • History of celiac disease.
  • History of cirrhosis of the liver or ascites.
  • Disease symptoms caused by a confirmed intestinal pathogen other than Clostridium difficile.
  • Has a colostomy.
  • Intraabdominal surgery within the last 60 days.
  • Evidence of active, severe colitis.
  • History of short gut syndrome or motility disorders.
  • Requires the regular use of medications that affect bowel motility (e.g., metoclopramide, narcotics, loperamide).
  • Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).
  • Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
  • Life expectancy of < 12 months.
  • Compromised immune system, e.g., HIV infection (any CD4 count); AIDS-defining diagnosis or CD4 <200/mm3; inherited/primary immune disorders; immunodeficient or immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy; or current or recent (< 90 days) treatment with immunosuppressant medications.
  • Taking steroids (≥ 20 mg a day) or is expected to be on steroids for more than 30 days after enrollment.
  • Neutropenia (white blood cell count <1000 cells/µL).

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Edward Hines Jr VA Hospital (veterans only)

    Chicago, Illinois, 60141

  • University of Chicago

    Chicago, Illinois, 60637

  • Denver Health and University of Colorado

    Denver, Colorado, 80204

  • Detroit Medical Center

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Sanford Research/USD

    Fargo, North Dakota, 58122

  • Borland-Groover Clinic

    Jacksonville, Florida, 32216

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic - Minnesota

    Rochester, Minnesota, 55905

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 2 Open-label Clinical Trial Demonstrating the Safety of RBX2660 Microbiota Suspension for the Treatment of Recurrent Clostridium Difficile-associated Diarrhea (CDAD): the PUNCH CD Study

This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.

Read the detailed description

This is the first study of a microbiota suspension derived from intestinal microbes. The primary assessments for this open label, multi-center study are (i) occurrence of product-related adverse events and (ii) resolution of CDAD at 56 days after administration of RBX2660. Subjects will also be assessed for time to CDAD recurrence, quality of life changes, and number of hospitalizations and length of stay for recurrent CDAD. Study visits will be at 7, 30, and 60 days after RBX2660 administration with additional follow-up at 3 and 6 months post treatment. Patients who have had at least two recurrences of CDAD after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDAD resulting in hospitalization may be eligible for the study.

Being tested
RBX2660 (microbiota suspension)
Keywords
Clostridium difficile, C diff, Microbiota Restoration Therapy, MRT, microbiota suspension, CDI, CDAD, Fecal transplant, Fecal Microbiota Transplant, FMT, Diarrhea, Fecal bacteriotherapy
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.

  • RBX2660 (microbiota suspension)Biological

Study groups in NCT01925417
Study groupRoleWhat they receive
RBX2660 (microbiota suspension)Experimentalenema-based delivery of RBX2660
Receives: Biological: RBX2660 (microbiota suspension)

What is being measured

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

  1. Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660

    Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.

    Measured: 56 days

Secondary outcomes (4)

  1. Long-term Safety

    The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.

    Measured: 6 months

  2. Absence of CDAD at 56 Days

    Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.

    Measured: 56 days

  3. Quality of Life (SF-36)

    Quality of Life (SF-36) will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.

    The scale is from 0-100, with higher scores meaning better outcomes.

    Measured: 60 days

  4. Post-treatment Hospitalization Data

    number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.

    Measured: 6 months

Timeline

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

  1. First posted19 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionMar 2014
  4. Study completionJul 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01925417
Sponsor's protocol ID
2013-001
Acronym
PUNCH CD
Status last verified
Sep 2018
First submitted
15 Aug 2013
Last updated
13 Nov 2019
Data monitoring committee
No

Publications

  • van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

    PubMed 23323867

  • Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.

    PubMed 22002980

  • Rohlke F, Stollman N. Fecal microbiota transplantation in relapsing Clostridium difficile infection. Ther Adv Gastroenterol. 2012 Nov;5(6):403-20. doi: 10.1177/1756283X12453637.

    PubMed 23152734

  • 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

  • Langdon A, Schwartz DJ, Bulow C, Sun X, Hink T, Reske KA, Jones C, Burnham CD, Dubberke ER, Dantas G; CDC Prevention Epicenter Program. Microbiota restoration reduces antibiotic-resistant bacteria gut colonization in patients with recurrent Clostridioides difficile infection from the open-label PUNCH CD study. Genome Med. 2021 Feb 16;13(1):28. doi: 10.1186/s13073-021-00843-9.

    PubMed 33593430

  • Orenstein R, Dubberke E, Hardi R, Ray A, Mullane K, Pardi DS, Ramesh MS; PUNCH CD Investigators. Safety and Durability of RBX2660 (Microbiota Suspension) for Recurrent Clostridium difficile Infection: Results of the PUNCH CD Study. Clin Infect Dis. 2016 Mar 1;62(5):596-602. doi: 10.1093/cid/civ938. Epub 2015 Nov 12.

    PubMed 26565008

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RBX2660 (microbiota suspension) in people with Recurrent Clostridium Difficile Infection, run by Rebiotix Inc. at 13 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 5 inclusion and 20 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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. 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 1 Jul 2015). 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?

Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660 (time frame: 56 days). 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 NCT01925417, which also lists 7 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 13 Nov 2019.

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