Survey results showed patients with a history of live biotherapeutic product therapy preferred rectally administered treatment while patients who had not received live biotherapeutic product therapy would be willing to consider it.
The majority of patients with Clotridoides difficile infection (CDI) are willing to use a rectally administered therapy, with most patients previously unwilling to receive rectally administered therapy citing fear of CDI recurrence and desire for a treatment not requiring bowel preparation.
A self-administered online survey delivered to 146 patients with CDI, results showed most who received rectally administered live biotherapeutic product therapy considered rectal administration easy, quick, and appealing due to the lack of need for bowel preparation. Patients who had not received live biotherapeutic product therapy also expressed desire for a treatment not requiring bowel preparation and were willing to consider a rectally administered treatment.1
“Restoration of the healthy microbiome is essential for reduction of rCDI, which carries a significant clinical burden given that 25% of initial CDI cases result in a first recurrence and, of these, up to 60% experience further recurrences,” wrote investigators.1 “The use of live biotherapeutic products to restore the disturbed microbiota is gaining acceptance as a useful adjunctive therapy following standard of care antimicrobials.”
The US Centers for Disease Control and Prevention estimates there are nearly 500,000 cases of CDI in the US each year, further noting 1 in 6 patients infected with CDI will get it again in the subsequent 2-8 weeks.2 CDI is often treated with antibiotics, but recurring CDI may require repeated antibiotics, probiotics, or fecal microbiota transplantation.3 Often, fecal transplantation is performed by colonoscopy.4
To assess perception of rectally administered microbiome therapy among patients with CDI, Paul Feuerstadt, MD, assistant clinical professor of medicine at Yale School of Medicine, and a team of investigators surveyed patients aged ≥18 years with at least 1 previous CDI episode within the previous 36 months. The cohort included 2 groups of patients: live biotherapeutic product recipients who received fecal microbiota live-jslm rectally as part of the phase 3 PUNCH CD3 clinical trial, and patients with no history of receiving live biotherapeutic product or fecal microbiota transplantation therapies.1
In total, 46 live biotherapeutic product recipients and 100 live biotherapeutic product naïve patients responded to the questionnaire. The live biotherapeutic product recipient group had a mean age of 62 years and 70% were female compared to a mean age of 46 years and 58% female patients in the live biotherapeutic product naive group.1
Among those with no history of live biotherapeutic product therapy, 45% experienced CDI within the previous 3–12 months and 66% had CDI in the prior 12 months. Of these patients, investigators noted 24% had undergone gastrointestinal surgery, 25% had been diagnosed with sepsis as a result of CDI, and 52% reported they had chronic disease, with high blood pressure (33%) and diabetes (29%) being the most common.1
Each participant completed 1 of 2 self-administered online surveys designed to assess sentiments toward rectal administration of a live biotherapeutic product. Investigators collected survey responses using an anonymized database via a dedicated link between June 2022 and January 2023.1
Investigators noted nearly all live biotherapeutic product recipients considered rectal administration easy (96%) and quick (94%), while 98% of participants considered the lack of need for bowel preparation appealing. Additionally, 96% of live biotherapeutic product recipients said they wished they had earlier access to live biotherapeutic product. Of these patients, 35% reported prior therapies were less effective, 13% believed their CDI would have improved sooner with earlier treatment, and 9% indicated the treatment had improved their quality of life.1
Among participants with no history of live biotherapeutic product therapy, 87% were likely or somewhat likely to consider a rectally administered treatment. Investigators pointed out 2% of patients were somewhat unlikely to consider it and none were very unlikely to consider it. Most patients in this group expressed interest in finding out about new treatment options for recurring CDI (76%). Of note, 73% of patients were fearful of a CDI recurrence and 81% considered CDI to be disruptive to their lives.1
“[Live biotherapeutic product]-recipients and [live biotherapeutic product]-naïve subjects alike felt that delivery of microbiome therapy directly to the site of the infection by a route that is convenient as a single dose, straightforward, and not complicated by the need for bowel preparation, anesthesia, or an endoscopy suite, is not only acceptable but highly interesting as a treatment avenue,” investigators concluded.1