In a bid to combat the resurgence of potentially debilitating Clostridioides difficile infection (CDI), healthcare professionals have pivoted towards new therapeutics. Clostridioides difficile, a bacterium that colonizes the gut, incites a disruption in the gut microbiome leading to dysbiosis, thereby paving the way for infections. Posing a higher risk to the elderly (over 65), the hospitalized, immunocompromised individuals and those with a previous CDI history, this infection induces severe diarrhea, fever, stomach discomfort, reduced appetite, nausea, and colitis.
Nearly 35% of diagnosed CDI cases could exhibit recurrences, leading to a cyclic effect of infection and causing significant strain on healthcare systems. On November 30, 2022, evolving our understanding of microbiome-based treatment, the FDA approved the single-dose solution, fecal microbiota, live – jslm (RBL). Created to prevent CDI recurrence in adults who have taken antibiotics for recurring CDI, this live biotherapeutic product is essentially a 150 mL pre-packaged microbiota suspension for rectal administration containing trillions of live microbes including Bacteroides. Sharon Rimon, NP, has been actively working with RBL since it became available in 2023. Rectal suspensions generally administered for managing localized colon diseases are not new interventions. The focus is on ensuring a rapid therapeutic response by delivering treatment directly to the gut microbiome. Rectal administration of RBL, held in a clinical environment, alleviates the patient’s burden and places responsibility within the domain of the healthcare provider. This method requires no prior bowel prep or anesthesia and constitutes a ‘one and done’ treatment in CDI recurrence prevention.
In terms of training requirements for HCPs, a study in 2023 advocates a well-established protocol for drug management, ordering, patient communication, and administration. As Rimon explains, enhancing real-world experience with RBL treatment can help streamline the process while keeping patients informed. Factoring in the preparation and observation periods, the procedure usually takes approximately 21 minutes. Post-RBL administration, patients can even drive themselves home, considering that the treatment does not necessitate anesthesia. The FDA-backed clinical trial data validates RBL’s superiority over placebo, reducing recurrent CDI following standard-of-care antibiotic treatment. Over 90% of participants who exhibited treatment success managed to remain free of CDI recurrence for up to 6 months. Adverse events were primarily mild-to-moderate, with no serious incidents reported.
Although retail pharmacists do not dispense or administer RBL, they play a pivotal role in patient education about the significance of a healthy microbiome and the potential of dysbiosis and infections. Being informed about new treatments, administration methods, dosing, and AEs becomes paramount for them, especially for those working in hospitals or health care centers. RBL can be ordered through specialty distributors and pharmacies and is typically delivered frozen to HCP offices for thawing before administration, with recommended ordering 2 to 4 days prior to the administration appointment.