Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Overview

About this study

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) 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 CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

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
Medical record documentation of recurrent CDI 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.

Exclusion Criteria:

A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
Requires antibiotic therapy for a condition other than recurrent CDI.
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.
History of celiac disease.
Colostomy.
Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
Life expectancy of < 12 months.
Compromised immune system.

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
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Robert Orenstein, D.O.	Closed for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert Orenstein, D.O.

Closed for enrollment

More information

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