Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.

10 participants were analyzed in the modified Intent-to-Treat (mITT) and Per Protocol (PP) populations. The mITT population includes all subjects who were treated and assessed at the TOC visit. The PP population consists of patients in the mITT population with no major protocol deviations.

Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.

PP participants were those in the ITT population who had no major protocol deviations. The ITT population is defined as all randomized subjects, analyzed according to their randomized treatment assignment.

Percentage of patients with CC at the test of cure (TOC) visit on day 12. CC was defined as survival and the resolution of diarrhea in the 24-hour period immediately before end of treatment (EOT--day 10) that was maintained for 48 hours post EOT without a requirement for additional CDI treatment. Diarrhea was defined as 3 or more unformed bowel movements (UBMs) in a 24-hour period; fewer than 3 UBMs was considered as resolution of diarrhea. A UBM was defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.

ITT population is defined as all randomized subjects, analyzed according to their randomized treatment assignment.

Clinical cure (CC) at the test of cure (TOC) visit (ie, at least 48 hours after end of treatment [day 10]) and no recurrence within 28 days. Recurrence was defined as a new episode of diarrhea (3 or more UBMs in a 24-hour period) with a positive toxin result, using a Sponsor-approved C. difficile free toxin test and, in the opinion of the Investigator, requiring retreatment with an antibacterial agent for C. difficile.

10 participants were analyzed in the modified Intent-to-Treat (mITT) and Per Protocol (PP) populations. The mITT population includes all subjects who were treated and assessed at the TOC visit. The PP population consists of patients in the mITT population with no major protocol deviations.

Clinical cure (CC) at the test of cure (TOC) visit (ie, at least 48 hours after end of treatment [day 10]) and no recurrence within 28 days. Recurrence was defined as a new episode of diarrhea (3 or more UBMs in a 24-hour period) with a positive toxin result, using a Sponsor-approved C. difficile free toxin test and, in the opinion of the Investigator, requiring retreatment with an antibacterial agent for C. difficile.

PP participants were those in the ITT population who had no major protocol deviations. The ITT population is defined as all randomized subjects, analyzed according to their randomized treatment assignment.

Clinical cure (CC) at the test of cure (TOC) visit (ie, at least 48 hours after end of treatment [day 10]) and no recurrence within 28 days. Recurrence was defined as a new episode of diarrhea (3 or more UBMs in a 24-hour period) with a positive toxin result, using a Sponsor-approved C. difficile free toxin test and, in the opinion of the Investigator, requiring retreatment with an antibacterial agent for C. difficile.

ITT population is defined as all randomized subjects, analyzed according to their randomized treatment assignment.

Plasma ibezapolstat concentrations were measured at specified day and time points following dose administration. Amount listed as zero not included in determination of Geometric Mean and CV%.

3 participants from the original population did not have plasma samples taken and were not included.

Plasma ibezapolstat concentrations were measured at specified day and time points following dose administration. Amount listed as zero not included in determination of Geometric Mean and CV%

3 participants from the original population did not have plasma samples taken and were not included. 1 participant from the original population did not receive the study drug and was not included.

Fecal ibezapolstat concentrations were measured for specified days following dose administration. Specified days were 3, 5, 8, 10, 12, 20, and 38. Amount listed as zero not included in determination of Geometric Mean and CV%.

Participants with undetectable concentrations were not included in the data.

Fecal ibezapolstat concentrations were measured for specified days following dose administration. Specified days were 3, 5, 8, 10, 12, and 20. Amount listed as zero not included in determination of Geometric Mean and CV%.

Participants with undetectable concentrations were not included in the data.

Time in days from outset of treatment to the first formed bowel movement not followed within the next 24 hours by an unformed bowel movement (UBM), defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.

10 participants were analyzed in the modified Intent-to-Treat (mITT) and Per Protocol (PP) populations. The mITT population includes all subjects who were treated and assessed at the TOC visit. The PP population consists of patients in the mITT population with no major protocol deviations.

Time in days from outset of treatment to the first formed bowel movement not followed within the next 24 hours by an unformed bowel movement (UBM), defined as a Type 5, 6, or 7 bowel movement on the Bristol Stool Chart.

The Per Protocol (PP) population is represented here. PP participants were those in the intention-to-treat (ITT) population who had no major protocol deviations. The ITT population is defined as all randomized subjects, analyzed according to their randomized treatment assignment.

The Shannon Diversity Index and Inverse Simpson Diversity Index are used to quantify biodiversity in a community like the gut microbiome, measuring how many different species are present in a community (richness) and how close in numbers different species in the community are to each other (evenness). The Shannon considers both factors while the Inverse Simpson focuses on evenness. The Shannon diversity index is calculated using natural logarithms, and units cancel out in the calculation, so it lacks units. It ranges from 0 to infinity. The Inverse Simpson represents the likelihood of selecting two different individuals from a population. It is a ratio and has no units. It ranges from 0 to 1. For both indexes, higher values indicate greater diversity.

8 of the 10 participants in Segment 2A provided stool samples and were analyzed. Not all 8 subjects were able to provide samples for all time points, so the data are not continuous. Data is reported as mean increase in biodiversity from the baseline.

Change from baseline in each of the 5 dimensions of the EQ-5D-5L score, each scored on a scale of 1-5, with 1 being normal and 5 indicating extreme difficulty or impairment. The 5 dimensions are mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Summary Index Scores (the 5 dimensions combined into a single value) are reported here. Values for the index score ranges from -0.59 to 1, where 1 is the best possible health state.

PP participants were those in the intent-to-treat (ITT) population who had no major protocol deviations. The ITT population is defined as all randomized subjects, analyzed according to their randomized treatment assignment.

Clinical cure (CC) at the test of cure (TOC) visit (ie, at least 48 hours after end of treatment [day 10]) and no recurrence within 56 days [day 66] or within 84 days [day 94]. Recurrence was defined as a new episode of diarrhea (3 or more UBMs in a 24-hour period) with a positive toxin result, using a Sponsor-approved C. difficile free toxin test and, in the opinion of the Investigator, requiring retreatment with an antibacterial agent for C. difficile.

Participants from the ITT population were recruited for an extended follow-up period. In the ITT extension population, 1 ibezapolstat subject failed at the CC (Day 12) and 1 vancomycin subject failed at the SCC (Day 38); both failures carried forward to both ECC evaluations. There were no failures post SCC (Day 38). In the ITT extension population who achieved a SCC, 5/5 ibezapolstat-treated participants and 7/7 vancomycin-treated participants experienced no infection recurrence.