Maria I. Vazquez Roque, M.D., M.S.

Closed for Enrollment

• A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection (CD3-OLS) Jacksonville, Fla.

  The purpose of this study is to evaluate 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.

• A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection Jacksonville, Fla.

  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 two recurrences 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 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 RBX2660 enema.

• A Pilot Study of Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients with Functional Gastrointestinal Disorders Jacksonville, Fla.

  The overall hypothesis of this research study is that gluten intake alters intestinal barrier function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac gluten sensitivity (NCGS).

• A Pilot Trial of Preoperative Oral Microbiota-Based Investigational New Drug, RBX7455 to Target Immune Response in Patients with Operable Stage I-III Breast Cancer Jacksonville, Fla.

  The primary purposes of this trial are to determine the safety and tolerability of RBX7455 given for at least 2 weeks and not more than 4 weeks prior to surgery, and to evaluate intratumoral immune system resonse, including TILs, CD4, and CD8 T cells, in operable breast cancer patients.

• A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4) (FIN-CDI-301 PRISM4) Jacksonville, Fla.

  The purpose of this trial is to evaluate the effectiveness, safety, and tolerability of a single oral administration of study drug CP101 for the prevention of recurrent Clostridioides difficile Infection (CDI) in adult patients.

  This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm (Part A) and an optional open-label treatment arm (Part B). After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized to receive either the study drug CP101 or placebo in Part A of the trial.  Patients will be evaluated for CDI recurrence and safety follow-up.

  Patients who experience an on-trial, central laboratory-positive C. difficile-related diarrhea are eligible for the open-label treatment (OLT) with the study drug CP101 in Part B of the trial. Patients in Part B will also be evaluated for CDI recurrence and safety follow-up.