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Clinical trialNCT03931941CompletedPhase 3Interventional

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

SponsorRebiotix Inc.Enrollment793Clostridium Difficile InfectionCommunicable DiseasesInfection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

51 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Calgary

    Calgary, Alberta, Canada

  • Edmonton

    Edmonton, Alberta, Canada

  • Vancouver

    Vancouver, British Columbia, Canada

  • Victoria

    Victoria, British Columbia, Canada

  • Moncton

    Moncton, New Brunswick, Canada

United States
  • Phoenix

    Phoenix, Arizona, United States

  • North Little Rock

    North Little Rock, Arkansas, United States

  • Oxnard

    Oxnard, California, United States

  • Aurora

    Aurora, Colorado, United States

  • Hamden

    Hamden, Connecticut, United States

  • Gainesville

    Gainesville, Florida, United States

  • Jacksonville

    Jacksonville, Florida, United States

  • Naples

    Naples, Florida, United States

  • Orlando

    Orlando, Florida, United States

  • Port Orange

    Port Orange, Florida, United States

  • Atlanta

    Atlanta, Georgia, United States

  • Decatur

    Decatur, Georgia, United States

  • Idaho Falls

    Idaho Falls, Idaho, United States

  • Burr Ridge

    Burr Ridge, Illinois, United States

  • Gurnee

    Gurnee, Illinois, United States

  • Fort Wayne

    Fort Wayne, Indiana, United States

  • Wichita

    Wichita, Kansas, United States

  • New Orleans

    New Orleans, Louisiana, United States

  • Shreveport

    Shreveport, Louisiana, United States

  • Baltimore

    Baltimore, Maryland, United States

  • Detroit

    Detroit, Michigan, United States

  • Plymouth

    Plymouth, Minnesota, United States

  • Rochester

    Rochester, Minnesota, United States

  • St. Louis

    St Louis, Missouri, United States

  • New York

    New York, New York, United States

  • Rochester

    Rochester, New York, United States

  • Durham

    Durham, North Carolina, United States

  • Fargo

    Fargo, North Dakota, United States

  • Cleveland

    Cleveland, Ohio, United States

  • Oklahoma City

    Oklahoma City, Oklahoma, United States

  • Philadelphia

    Philadelphia, Pennsylvania, United States

  • Pittsburgh

    Pittsburgh, Pennsylvania, United States

  • Wyomissing

    Wyomissing, Pennsylvania, United States

  • Charleston

    Charleston, South Carolina, United States

  • Hixon

    Hixon, Tennessee, United States

11 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

RBX2660
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jul 2019
Primary completion
21 Jul 2023
Completion
21 Jul 2023
Last update posted
7 Aug 2024
Registered enrollment
793
Registry id
NCT03931941
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.