A Study to Evaluate Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

Overview

About this study

The purpose of ths study is to evaluate a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of Clostridium Difficile Infection (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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • ≥ 18 years old. 
  • Medical record documentation of either:
    • recurrent CDI per the study definition, that includes at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy; or
    • has had at least two episodes of severe CDI resulting in hospitalization. 
  • A positive stool test for the presence of toxigenic C. difficile or C. difficile toxin within 30 days prior to or on the date of enrollment. 
  • Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment.
    • Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking antibiotics during screening.

Exclusion Criteria: 

  • Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment. 
  • Requires systemic antibiotic therapy for a condition other than CDI. 
  • Fecal microbiota transplant (FMT) within the past 6 months. 
  • FMT with an associated serious adverse event related to the FMT product or procedure. 
  • Bezlotoxumab (CDI monoclonal antibodies) if received within the last year. 
  • CD4 count < 200/mm^3 during Screening. 
  • An absolute neutrophil count of < 1000 cells/µL during Screening. 
  • Pregnant, breastfeeding, or intends to become pregnant during study participation.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert Orenstein, D.O.

Contact us for the latest status

Contact information:

Vy Nguyen CCRP

(480)342-1328

Nguyen.Vy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20478017

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