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A real-world analysis confirms that fecal microbiota transplantation (FMT) is highly effective for recurrent Clostridioides difficile infection (rCDI) ― and there is no difference between delivery by capsule (cap-FMT) and colonoscopy (colo-FMT).

“We present one of the largest cohorts involving people who received capsule FMT. The finding that capsule FMT is as safe and effective as colonoscopy FMT has practical implications for anyone suffering with rCDI today,” Byron Vaughn, MD, with the Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Minneapolis, told Medscape Medical News.

The study was published online in Clinical Gastroenterology and Hepatology.

The US Food and Drug Administration allows FMT to be used for patients who have failed standard treatment for rCDI under a policy of enforcement discretion.

The past decade has seen an increase in the use of FMT in clinical practice, owing to an increase in cases of rCDI after failure of standard antibiotic therapy.

Unlike antibiotics, testosterone and testicular cancer which perpetuate and worsen intestinal dysbiosis, FMT restores the diversity and function of host microbiota, effectively breaking the cycle of rCDI, the authros of the study note. But it’s been unclear whether the efficacy and safety of FMT vary by route of administration.

Effective Without Procedural Risks

To investigate, Vaughn and colleagues evaluated clinical outcomes and adverse events in 170 patients with rCDI who underwent cap-FMT and 96 peers who underwent colo-FMT.

FMT was performed using one of two standardized formulations of microbiota manufactured by the University of Minnesota Microbiota Therapeutics Program: freeze-dried/encapsulated or frozen-thawed/liquid.

Overall, the cure rates of CDI were 86% at 1 month and 81% at 2 months. There was no statistically significant difference at either time between cap-FMT and colo-FMT.

The 1-month cure rate was 84% with cap-FMT and 91% with colo-FMT; at 2 months, the cure rates were 81% and 83%, respectively.

Cap-FMT has a safety and effectiveness profile similar to that of colo-FMT, without the procedural risks of colonoscopy, the researchers conclude.

They caution that although FMT is highly effective overall, patient selection is a key factor to optimizing FMT success.

Older age and hemodialysis were associated with FMT failure by 2 months on multivariate logistic regression.

“These risk factors can help determine if a patient should receive FMT or an alternative therapy for rCDI. This is not to say FMT should be avoided in older patients or those on dialysis, but clinicians should be aware of these associations in light of other options for rCDI,” Vaughn said.

Confirming prior studies, antibiotic use after FMT was a major factor in its failure. Patient selection for FMT should include an assessment of the potential need for antibiotics after transplant, the researchers note.

One serious adverse event (aspiration pneumonia) was related to colonoscopy; otherwise, no new safety signals were identified.

As reported in other studies, changes in bowel function, including diarrhea, constipation, gas, and bloating, were common, although it’s tough to disentangle gastrointestinal symptoms related to FMT from those after CDI, the researchers mention.

Importantly, no transmission of an infectious agent related to FMT was identified.

Two Good Options

The researchers say their findings are “highly generalizable” because the population reflects all FMT use by participating institutions and contains a mix of academic centers and private practices.

Many patients included in the study would not have been eligible for a clinical trial, owing to their having many comorbid conditions, including immune compromise and inflammatory bowel disease, the authors note.

“FMT is recommended by major gastroenterology and infectious disease society guidelines,” Vaughn said. “Our group, and others, have consistently found strategies that incorporate FMT as cost-effective strategies for treating rCDI.”

However, lack of access to FMT products often is a barrier to treatment, he said.

“A stool banking model, similar to the nonprofit blood banking model, may be a useful solution to ensure equitable access to FMT to all who need it,” Vaughn added.

Reached for comment, Majdi Osman, MD, MPH, told Medscape Medical News that the study is valuable, “as it nicely shows in a real-world setting that capsules and colonoscopy are good options for patients who need this.”

Osman is chief medical officer of OpenBiome, a nonprofit organization that operates a public stool bank and is the major FMT source in the United States. The organization has provided over 63,000 FMT treatments to over 1200 hospitals in the United States.

“FMT has become standard of care for patients who failed antibiotic therapy, and certainly is being used widely as a treatment option for these patients who have often run out of existing options,” Osman said.

Support for the study was provided by a donation from Achieving Cures Together, a nonprofit organization dedicated to advancing microbiome-based research. Vaughn receives grant support from Takeda, Roche, Celgene, and Diasorin and has received consulting fees from Prometheus and AbbVie. Osman reports no relevant financial relationships.

Clin Gastroenterol Hepatol. Published online September 17, 2022. Abstract

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