Oral drug made from human feces has successfully passed clinical trials

Fecal microbiota transplantation (FMT), while disgusting, does offer a proven solution for those battling C.

Stools from healthy donors, often delivered to recipients via colonoscopy, can help restore the balance of gut microbiota, thereby eliminating potentially fatal infections

Several companies are eager to achieve the same effect with less invasive, more standardized treatments that could be approved by U.

One option is a pill with bacterial spores isolated from human feces, which has now successfully undergone Phase 3 clinical trials, paving the way for the first approval of such a drug

FMT can break the cycle of repeated C.

FMT has been part of mainstream medicine for about 10 years, said Sahil Khanna, a gastroenterologist at the Mayo Clinic who participated in previous clinical trials of SER-109

In some recent cases, inadequate screening of donor stool has spread harmful new infections to patients

"I think we've made it as safe as possible," Kelly said.

The nonprofit fecal bank OpenBiome, the largest supplier in the U.

The new drug, called SER-109, made by Seres Therapeutics (hereafter called Seres), is extracted from human feces and purified to reduce microbes in the body

Seres chief medical officer Lisa von Moltke said such bacteria are valuable because they can compete with C.

Seres' purification process is designed to remove most pathogens known to pose safety risks to patients, said Vincent Young, a microbiologist and infectious disease physician at the University of Michigan, Ann Arbor.

In 2016, in a phase II clinical trial, Seres announced that its treatment had failed to show a greater benefit than a placebo

A higher dose and more precise screening test was used in the Phase 3 clinical trial, which included 182 C.

The researchers reported that 40 percent of the placebo group experienced a recurrence of C.

Results of the study were published in the January 20, 2022 issue of the NEJM journal, titled "SER-109, an oral microbiome therapy for recurrent Clostridium difficile infection

These results are comparable to those observed with FMT, Kelly said
.
Many patients want to avoid the discomfort of colonoscopies, and if they have pills, they choose to take them, she said
.
(She noted that while the "full spectrum" fecal microbiota can also be taken orally, there are few suppliers of such pills in the United States
.
)

Some scientists doubt that the new treatment can match the potency of the full fecal microbiome
.
"It's a very high bar set by nature," said Alexander Khoruts, a gastroenterologist at the University of Minnesota Twin Cities
.

He noted that the fecal components removed during Seres' purification process included germ-killing viruses called bacteriophages
.
, may be important to the success of FMT
.
"I'm happy that Firmicutes alone is better than a placebo, but I don't necessarily think the other ingredients can be ignored,
" he said.

Young sees SER-109 as a "bridge" from FMT to more personalized treatments, and he hopes that when scientists can better analyze a patient's gut microbiome and figure out which microbes they need, personalized treatments will emerge
.

Seres aims to submit an application for approval to the FDA for SER-109 by mid-2022, von Moltke said
.
several competitors
.
Last year, Microbiome company Rebiotix announced positive results from a Phase 3 clinical trial of its relapsed-refractory C.
difficile therapy
.

In October 2021, Finch Therapeutics, a subsidiary of OpenBiome, announced the successful Phase 2 clinical trial of its product, a tablet containing freeze-dried stool
.

Vedanta Biosciences has completed a Phase 2 clinical trial of a C.
difficile therapy consisting of eight individually selected strains grown in cell banks rather than isolated from feces
.

With the advent of alternatives to FMT, "I don't want to see the fecal bank model disappear entirely," Kelly said
.
She noted that intact stool remains important for research into developing treatments for other diseases, such as inflammatory bowel disease
.

However, she is eager to see SER-109 applied to C.
difficile patients
.
"I think everyone is happy to have something safe and ready
.
Hopefully it won't be too expensive," she said
.

1.
Pill derived from human feces treats recurrent gut infections https:// 2.
Paul Feuerstadt et al.
SER-109 , an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection.
NEJM, 2022, doi:10.
1056/NEJMoa2106516.

Oral drug made from human feces has successfully passed clinical trials