Fecal microbiota transplants (FMT) performed via oral capsule or colonic conduction have shown similar safety and efficacy to repeat. Clostridium difficile infection (CDI) in a prospective study.
In the cohort of 269 patients, no significant differences in 1- or 2-month cure rates were observed between the capsule or endoscopic FMT groups:
- 1 month: 84% vs 91% (s= 0.12)
- 2 months: 81% vs 83% (s= 0.70)
Regardless of the route of administration, post-transplant antibiotic use not associated with CDI was associated with FMT failure, with failure rates of 28% versus 10% for patients who did not receive subsequent antibiotics (s= 0.03), according to Byron Vaughn, MD, MS, of the University of Minnesota in Minneapolis, and colleagues.
“Attention should be given to patient selection based on the subsequent potential for antibiotic requirements,” the group wrote in. Clinical gastroenterology and hepatology. “If a patient appears to require a repeat course of antibiotics, extending oral vancomycin or considering bezlotoxumab may be effective alternatives.”
In the multivariate analysis, other factors significantly associated with a greater risk of FMT failure included age 65 or older (OR 2.6, 95% CI 1.2-5.9) and needing dialysis (OR 9.4, 95% CI 2.0-43.8).
The Vaughn group noted that the widespread adoption of FMT in clinical practice, which is supported by guiding ruleswas driven by the increased incidence of recurrent CDI in patients who had failed standard antibiotics.
“In contrast to antibiotic treatments, which both perpetuate and worsen intestinal dysplasia, FMT restores the diversity and function of the host microorganisms, effectively breaking the cycle” of recurrent CDI, the group explained.
They note that “treatment with oral capsules offers advantages in ease of delivery, lack of a laxative, and absence of risks associated with colonoscopy.” “In contrast, endoscopic administration transports the bacteria into their designated compartment in the intestine and enables diagnostic evaluation of the colonic mucosa.”
But safety and efficacy varied with different routes of administration, and previous trials largely excluded patients with multiple comorbidities.
For their study, Vaughn and colleagues examined data from the American Gastroenterological Association’s National Patient Registry. Across six centers from July 2019 to October 2021, a total of 269 patients with recurrent CDI received capsule (n = 170) or colonoscopic FMT formulations (n = 96) manufactured by the University of Minnesota Microbiota Therapy Program (MTP).
The route of administration was determined by the attending physician, and FMT formulations consist of either oral capsules and lyophilized (MTP-101C) or a frozen thawed liquid suspension preserved with glycerol for colonoscopy (MTP-101LR . Device).
The rates of recurrent CDI treatment in the overall population were 86% (95% CI 82-90) at 1 month and 81% (95% CI 75-86) at 2 months. Among patients who relapsed treatment after their first FMT, 41% underwent repeat procedures (range 2-4), and the cure rate in this subgroup was 82% at 2 months.
The study authors note that adverse events were similar between groups, and consistent with other reports. Changes in bowel function were common, including diarrhea (29% in the first week), constipation (12%), gas (22%) and bloating (15%). However, Vaughn and colleagues note that gastrointestinal symptoms associated with FMT are difficult to distinguish from recurrent CDI symptoms.
Only one serious adverse event of aspiration pneumonia associated with colonoscopy occurred, but no other new safety indications were reported. One patient died of natural causes in the FMT capsule group.
The vast majority of patients were white, and 72% were women. Overall, 38% were hospitalized for CDI, and 88% had two or more episodes of recurrent CDI in the previous year.
Patients in the FMT capsule group tended to be older (median 68 vs 54 years), but less likely to have IBD (9.4% vs. 18%) or immunosuppression (18% vs. 30%) than those in the endoscopy group colon.
Limitations of the data involved in this course of management may be subject to selection bias. In addition, due to the risk of infectious disease transmission, FMT requires rigorous donor screening, and multistep laboratory testing may have an impact on recurrence rates.
This study was supported by Achieving Cures Together, a non-profit organization.
Vaughn reported support from Abbvie, Celgene, Diasorin, Prometheus, Roche, and Takeda. The co-authors disclosed their relationships with Finch Therapeutics, Merck, OpenBiome (the primary FMT source in the US), Rebiotix and Seres.