Clinical Trial Search

Primary: Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) — 25; 19; 20; 25 Participants

Primary: Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660 — 10 number of reported SAEs through 56 days

Primary: Efficacy of RBX2660 Compared to Placebo Through 8 Weeks — 57.5; 70.6 Model-estimated percent of participants

Primary: Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern — 100 percentage of participants

Primary: Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks — 112; 23; 30; 52 Participants

Primary: Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication — 76; 59 Participants — p=0.0488

Primary: Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI. — 697 Participants

Primary: Number of Subjects With CDI Recurrence — 26; 16 participants

Primary: Safety as Assessed by Number of Participants With Any Adverse Events (AE)s — 4; 4 Participants — p=0.8958

Primary: Safety of Fresh, Frozen or Lyophilized Intestinal Bacteria From Healthy Donors Given by Colonoscopy for Therapy in Subjects With Recurrent C. Difficile Associated…

Primary: Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. — 56; 33; 149; 7…

Primary: Recurrent Clostridium Difficile Infection (CDI) — 17; 24 Participants — p=0.22

Primary: Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment — 4; 9 Participants — p=0.228

Primary: Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD) — 7; 25 Participants

Primary: CDI Recurrence Week 8 — 4; 9; 5; 4 Participants

Primary: Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment — 61; 58; 59 participants

Primary: No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT — 106 participants

Primary: Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT) — 83.4; 82.1 Adjusted percentage of participants

Primary: Clinical Cure: Resolution of Diarrhea — 54; 44 Participants — p=0.195

Primary: Recurrence of CDI up to 8 Weeks — 11; 37 Participants — p=<0.001

Primary: Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication — 106 Participants

Primary: Cohort 1: Recurrence of CDI and Sustained Clinical Response — 4; 25 Participants

Primary: Clinical Remission Rates — 3; 2 Participants

Primary: Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) — 79.0; 83.6 Percentage of participants

Primary: Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population — 83.8; 85.2 Percentage of participants

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 37; 33; 34; 31 Participants

Primary: Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment…

Primary: Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal…

Primary: Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population — 81; 85.7 Percentage of participants

Primary: Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14 — 2083.3; 3189.4; 32096.4 EU/mL — p=0.5746