Administering Live Biotherapeutic Products

In recent years, the FDA approval of live biotherapeutic products (LBPs) had offered clinicians and patients a new modality to treat recurrent Clostridioides difficile infection (CDI). One of these approved products is LBP live-jslm (Rebyota, RBL), which was given the FDA nod as the first fecal microbiota product available in the US in November 2022.¹

The safety and efficacy of the treatment were assessed in 2 randomized, double-blind, placebo-controlled clinical studies and from numerous other open-label studies. Statistical analyses of treatment efficacy suggest recurrent CDI was prevented in 70.6% of recipients, as compared to 57.5% reduction of placebo recipients.¹

“The treatment can start as soon as their first C Diff recurrence,” explains Candace Cotto, RN, clinical research nurse, Medical Research Center of Connecticut, about the types of patients who are eligible for it. “So, they don't have to wait, if they have noticed that they've recurred...They have to finish their routine standard of care antibiotic, and they have to be off of their antibiotics from anywhere from 24 to 72 hours prior to the administration of the product."

Cotto’s center has been using this modality and doing the procedure for years going back to clinical trials. She offered some insights on the procedure.

This LBP is administered as 1 dose rectally, she explained. “The patient is placed on their left-hand side, almost in a fetal position,” said Cotto. “It's administered directly. The tube itself is inserted after some lubricant is put on the end of the tubing, and it is about the size of a number 2 pencil. Once they're on their side, you open the clamp, you lift up the bag, and it goes in by gravity.”

She also says there are not any specific instructions or special precautions before the procedure. There is no preparation before the procedure like taking laxatives, or a colonoscopy, or fasting the morning of administration.

“Once they're done, I have them sit up, and if they feel fine, they can go back to work; they can go home, or they can do whatever they need to do,” Cotto said. “They do not need assistance of anyone…it is very important to educate the patient before they come in and explain to them how easy the procedure is.”

Reference

Cosdon, N. FDA Approves First-Ever Fecal Microbiota, RBX2660, for C Difficile Recurrence. ContagionLive. November 30, 2022. Accessed January 24, 2022. https://www.contagionlive.com/view/fda-approves-first-ever-fecal-microbiota-rbx2660-for-c-difficile-recurrence