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Clinical trialNCT03244644CompletedPhase 3Interventional

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

SponsorRebiotix Inc.Enrollment320Clostridium Difficile Infection (CDI)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence 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 Clostridioides difficile infection (CDI) resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.
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

66 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 Columba, Canada

  • Victoria

    Victoria, British Columbia, Canada

  • Fredericton

    Fredericton, New Brunswick, Canada

  • Moncton

    Moncton, New Brunswick, Canada

United States
  • Athens

    Athens, Alabama, United States

  • Dothan

    Dothan, Alabama, United States

  • Phoenix

    Phoenix, Arizona, United States

  • North Little Rock

    North Little Rock, Arkansas, United States

  • Lancaster

    Lancaster, California, United States

  • Los Angeles

    Los Angeles, California, United States

  • Oxnard

    Oxnard, California, United States

  • Sacramento

    Sacramento, California, United States

  • Aurora

    Aurora, Colorado, United States

  • Hamden

    Hamden, Connecticut, United States

  • Gainesville

    Gainesville, Florida, United States

  • Jacksonville

    Jacksonville, Florida, United States

  • Miami

    Miami, Florida, United States

  • Port Orange

    Port Orange, Florida, United States

  • Atlanta

    Atlanta, Georgia, United States

  • Atlanta

    Atlanta, Georgia, United States

  • Idaho Falls

    Idaho Falls, Idaho, United States

  • Gurnee

    Gurnee, Illinois, United States

  • Highland Park

    Highland Park, Illinois, United States

  • Maywood

    Maywood, Illinois, United States

  • Lafayette

    Lafayette, Indiana, United States

  • Topeka

    Topeka, Kansas, United States

  • Wichita

    Wichita, Kansas, United States

  • Lexington

    Lexington, Kentucky, United States

  • New Orleans

    New Orleans, Louisiana, United States

  • Shreveport

    Shreveport, Louisiana, United States

  • Boston

    Boston, Massachusetts, United States

  • Detroit

    Detroit, Michigan, United States

  • Plymouth

    Plymouth, Minnesota, United States

  • Rochester

    Rochester, Minnesota, United States

  • St. Louis

    St Louis, Missouri, United States

  • Omaha

    Omaha, Nebraska, United States

  • Omaha

    Omaha, Nebraska, United States

  • Las Vegas

    Las Vegas, Nevada, United States

26 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.

Open label RBX2660PlaceboRBX2660
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
31 Jul 2017
Primary completion
2 Apr 2020
Completion
3 Aug 2020
Last update posted
10 Jul 2024
Registered enrollment
320
Registry id
NCT03244644
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.