Making Sense of Differing Guidelines for Clostridioides difficile Infection.

The Clostridioides difficile infection (CDI) epidemic has been impacting the world for years. Understanding accurate diagnostics is imperative to allow the appropriate patients to be treated and improve outcomes. This article leverages multiple global societal guidelines to focus on the evolving diagnostic tests available summarizing best diagnostic practices including 2-step diagnostic testing.

Safety and Efficacy of Fecal Microbiota, Live-jslm to Prevent Recurrent Clostridioides difficile Infection in Participants With Irritable Bowel Syndrome.

Introduction: The safety and efficacy of microbiota-based products in patients with irritable bowel syndrome (IBS) and recurrent Clostridioides difficile infection (rCDI) has not been studied. Fecal microbiota, live-jslm (RBL; REBYOTA) is an FDA-approved, single-dose, microbiota-based product to prevent rCDI in adults following standard-of-care (SOC) antibiotic treatment. This was an exploratory subgroup analysis of PUNCH CD3-OLS, a phase 3, open-label, prospective study conducted in the United States (US) and Canada, to evaluate the safety and efficacy of RBL in participants with documented rCDI and concurrent IBS.

Assessment of real-world disease severity in patients with eosinophilic esophagitis in the United States.

Background: Eosinophilic esophagitis (EoE) disease severity is not typically reported in clinical practice.

Objectives: To assess real-world EoE disease severity (assessed by physicians and using an adapted Index of Severity for EoE (I-SEE)), physician/patient characteristics, healthcare resource utilization (HCRU), and treatment patterns among adolescents and adults with EoE in the USA.

Design: A noninterventional, retrospective, physician-reported medical chart review.

Economic Burden of Patients With Chronic Idiopathic Constipation in the USA Before and After Prucalopride Initiation.

Background And Aims: Chronic idiopathic constipation (CIC) is associated with substantial health care resource utilization (HCRU) and economic burden; however, real-world evidence on the impact of treatment initiation on HCRU and health care costs are limited. We evaluated HCRU and direct health care costs associated with prucalopride initiation in patients with CIC in the United States.

Methods: Data were collected between January 1, 2015, and June 30, 2020, from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases for 690 adults with ≥ 1 prescription fill for prucalopride and ≥ 1 constipation-related diagnosis code.

Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy for prevention of recurrent infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial.

Background: Recurrent infection (rCDI) occurs in up to 35% of patients with CDI, and further recurrence is common. Fecal microbiota, live-jslm (RBL) is safe and effective for preventing rCDI in adults following antibiotic treatment for rCDI when administered rectally. There is clinical interest in alternative routes of administration.

Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS.

Background: Fecal microbiota, live-jslm (RBL; REBYOTA®), is the first single-dose, broad consortia, microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent recurrent Clostridioides difficile infection (rCDI) in adults following standard-of-care antimicrobials. Inflammatory bowel disease (IBD) is a common risk factor for rCDI, yet patients with IBD are often excluded from prospective trials. This subgroup analysis of PUNCH CD3-OLS (NCT03931941) evaluated the safety and efficacy of RBL in participants with rCDI and IBD.

Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies.

Background: Prucalopride (1 or 2 mg once daily) is approved for treating adults with chronic idiopathic constipation (CIC).

Objectives: We determined the effect of age, body mass index (BMI), and renal function on the efficacy and safety of prucalopride in adults with CIC.

Design: Data were pooled from six 12-week, phase III-IV clinical studies in adults who received prucalopride (1 or 2 mg once daily) or placebo for CIC.

Endoscopic diagnosis and management of adult inflammatory bowel disease: a consensus document from the American Society for Gastrointestinal Endoscopy IBD Endoscopy Consensus Panel.

Endoscopy plays a key role in diagnosis, monitoring of disease activity, assessment of treatment response, dysplasia surveillance, postoperative evaluation, and interventional therapy for patients with inflammatory bowel disease (IBD). Clinical practice patterns in the endoscopic management of IBD vary. A panel of experts consisting of IBD specialists, endoscopists, and GI pathologists participated in virtual conferences and developed this modified Delphi-based consensus document to address endoscopic aspects of IBD management.

Safety and Tolerability of CP101, a Full-Spectrum, Oral Microbiome Therapeutic for the Prevention of Recurrent Clostridioides difficile Infection: A Phase 2 Randomized Controlled Trial.

Background & Aims: Recurrent Clostridioides difficile infections (CDIs) remain common. While novel microbiome therapeutics gain approval, the efficacy of a full-spectrum, oral microbiome therapeutic is unknown. This study aimed to determine the safety and efficacy of CP101, an orally administered microbiome therapeutic, to restore a diverse microbiome and prevent recurrent CDI in a broad population.

A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States.

Background: At present, 4 prescription therapies have been approved by the US Food and Drug Administration for the treatment of chronic idiopathic constipation (CIC) in adults.

Objectives: To compare persistence with and adherence to prucalopride vs 3 other prescription medications for CIC in a US population.

Methods: This retrospective, observational cohort study used data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases (January 2015-June 2020).

Frailty is a predictor for worse outcomes in patients hospitalized with infection.

Background: Frailty has major health implications for affected patients and is widely used in the perioperative risk assessment. The Hospital Frailty Risk Score (HFRS) is a validated score that utilizes administrative billing data to identify patients at higher risk because of frailty. We investigated the utility of the HFRS in patients with infection (CDI) to determine whether they were at risk for worse outcomes and higher healthcare resource utilization.

Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.

Introduction: Recurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to prevent rCDI following antibiotics for rCDI.

Objective, Design, And Patients: To evaluate safety and efficacy of VOS from two phase 3 trials, (randomized, placebo-controlled [ECOSPOR III: NCT03183128] and open-label, single arm [ECOSPOR IV: NCT03183141]) of 349 adults with rCDI and prevalent comorbidities.

The Progression of Microbiome Therapeutics for the Management of Gastrointestinal Diseases and Beyond.

There has been an increased ability to investigate the human microbiota through next-generation sequencing and functional assessment. This advancement has rapidly expanded our ability to study and manipulate the gastrointestinal microbiome to mitigate disease. Fecal microbiota transplantation, a therapy that broadly transfers the entire intestinal ecosystem, has been explored as a potential therapeutic in a variety of gastrointestinal, hepatic, and extraintestinal conditions.

Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA) administered by colonoscopy under enforcement discretion for the prevention of recurrent infection.

Background: Fecal microbiota, live-jslm (RBL; REBYOTA), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing infection (CDI) recurrence. Alternative routes of administration are of clinical interest.

Objectives: Evaluate the safety and efficacy of RBL administration colonoscopy.

Clinical Outcomes Before and After Prucalopride Treatment: An Observational Study in Patients With Chronic Idiopathic Constipation in the United States.

Introduction: This real-world US-based claims study compared constipation-related symptoms and complications 6 months before and after prucalopride initiation in adults with chronic idiopathic constipation (CIC).

Methods: This observational, retrospective cohort analysis used the IBM MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental Database (January 2015-June 2020). Prucalopride-treated patients (≥18 years old) who had ≥1 constipation-related International Classification of Diseases, Tenth Revision, Clinical Modification ( ICD-10-CM ) diagnosis code during the baseline or study period were included.

Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection.

Introduction: Clostridioides difficile infection (CDI) causes symptoms of varying severity and negatively impacts patients' health-related quality of life (HRQL). Despite antibiotic treatment, recurrence of CDI (rCDI) is common and imposes clinical and economic burdens on patients. Fecal microbiota, live-jslm (REBYOTA [RBL]) is newly approved in the USA for prevention of rCDI following antibiotic treatments.

Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection : Subgroup Analysis of PUNCH CD2 and PUNCH CD3.

Goals: To assess fecal microbiota, live-jslm (REBYOTA, abbreviated as RBL, formerly RBX2660) efficacy and safety in participants grouped by recurrent Clostridioides difficile infection (rCDI) risk factors and treatment-related variables.

Background: RBL is the first microbiota-based live biotherapeutic approved by the US Food and Drug Administration for the prevention of rCDI in adults after antibiotic treatment for rCDI.

Study: Treatment success rates across subgroups for PUNCH CD3 (NCT03244644) were estimated using a Bayesian hierarchical model, borrowing data from PUNCH CD2 (NCT02299570).

Patient Perception of Route of Rectal Administration of Live Biotherapeutic Product for Recurrent Infection.

Introduction: CDI is a recurrent disease that is treated with antibiotics, but patients commonly experience repeat infections with significant impacts on hospital budgets and patient health quality. Standard of care management includes the antibiotics, vancomycin and fidaxomicin, which frequently provide clinical response, but do not avoid recurrence of infection (rCDI). These recurrent infections occur due to dysbiosis of the colonic microbiota.