Data Show Rectal Administration of Fecal Microbiota for Recurrent CDI Safe, Simple for Routine Clinical Practice

A new multi-disciplinary protocol could make it feasible to administer fecal microbiota live-jslm (RBL; Rebyota, Ferring Pharmaceuticals) for the treatment of recurrent clostridioides difficile infection (rCDI) in the routine clinical setting, according to a poster presented at the IDWeek conference in Boston, Massachusetts. The protocol enables infectious disease (ID) physicians and other health care providers at physician office infusion centers (POICs) to manage and treat patients with rCDI.

“Several of our clinics refer to ID offices and several administer [RBL] themselves. It is totally up to the doctors’ preference, but patient experience has been good,” Timothy Ritter, MD, of GI Alliance in Southland, Texas, said in a recent interview with Pharmacy Times.

Approximately 35% of patients with clostridioides difficile infection (CDI) experience recurrence after the first episode, but the standard of care (SoC) antibiotic treatment may worsen risk of recurrence because it destroys the diversity of the gut microbiota.

Approximately 35% of patients with clostridioides difficile infection (CDI) experience recurrence after the first episode, but the standard of care (SoC) antibiotic treatment may worsen risk of recurrence because it destroys the diversity of the gut microbiota. Image Credit: © Dr_Microbe - stock.adobe.com

Fecal microbiota RBL acts opposite to SoC—it is a rectally administered, pre-packaged, live biotherapeutic that dually works to restore the health and diversity of the gut microbiota and reduce risk of rCDI. RBL was the first ever FDA-approved microbiota product indicated for the treatment and prevention of rCDI in adults, but there is limited data on the feasibility of rectally administering RBL in the ID (or other) clinical practice setting.

Investigators conducted a study to fill this knowledge gap. The aim of the study was to develop a multi-disciplinary protocol that outlines the administration of RBL for rCDI in routine clinical practice, and to evaluate the feasibility of rectal RBL administration in routine clinical practice based on directions outlined in the protocol.

Data (including patient demographics, CDI history, time from order to treatment, and adverse events (AEs) from the procedure) was collected on 25 adult patients with rCDI who received at least 1 RBL from a POIC (n=12) that followed the protocol; it was collected between February and August 2023.

Upon analysis, investigators determined that a multi-disciplinary protocol is critical for enabling the rectal administration of RBL in the routine clinical setting to patients suffering from rCDI, according to findings from the poster. Investigators list key reasons the protocol was successful, such as that it allowed providers to quickly collect patient records required for insurance to approve the treatment; it also allowed for the quick acquisition and submission of a Certificate of Medical Necessity and STAT, respectively.

In addition, nurses could readily learn the protocol and tasks necessary to execute it (ie, drug ordering, patient communication, and administration), and it was quick to order the procedure. Moreover, the average time from order to treatment was a 2.7 weeks, according to study results.

“Overall, the [administration] process went well once it was fully understood,” Ritter said. Additionally, the procedure itself was complete in approximately 6 minutes, with no adverse events or leakage, and all patients adhered to the appointment date.

The administration protocol highlights the clinical and administration procedures that should be used across POICs. Drafted by a team of nurses, pharmacists, and administrators, the protocol outlines the tasks necessary for appointment coordination (such as discontinuing antibiotic therapy at least 72 hours prior to RBL procedure), pre-appointment confirmation (at which time the RBL will be taken out of refrigeration to thaw), and RBL administration guidelines (from preparing patients for treatment to administering it).

“The primary thing is just spreading education about when and how to use the product and continuing to explain the administration and logistics process,” Ritter said.

Reference

Hengel RL, Krishan S, Rosenberg JA, et al. Early Experience with a Simple Administration of a Novel Fecal Microbiome Replacement for Prevention of Recurrent Clostridioides difficile. Poster presented at: IDWeek conference; October 11 to 15, 2023; Boston, Massachusetts. Accessed October 17, 2023.