There's no way around it, so I'll be direct. The FDA has given the green light to a very particular pill, made of human fecal matter, to fight bacterial infections in the intestine. The “fecal transplant” in pills, developed by Seres Therapeutics, could open up a world of possibilities for treating different diseases simply by targeting our microbiome.
The company CEO, Eric Shaff, did not hesitate to call it “a crucial moment for the sector”. I can't imagine the comments on the news on our social channels. Would you like to know more?
Our intestines? A jungle of microorganisms
In our digestive tract there are billions of microorganisms that form the so-called "intestinal microbiome". While it may seem scary, these little hosts are mostly harmless and often helpful: They help us digest food, produce vitamins, support the immune system, and much more.
The makeup of our gut microbiome has been linked to a myriad of conditions, from trough to cancer, passing through the stroke. A delicate ecosystem that can be affected by many factors, including diet, ancestry, medications and even our social environment.
The “fecal transplant” as a treatment tool
Infection with Clostridium difficile is the perfect example of how an imbalanced gut microbiome can affect our health. It usually occurs in patients who have recently taken antibiotics, because these drugs can kill bacteria that compete with the Clostridium difficile for resources.
To help restore balance, people with severe or recurrent infections from Clostridium difficile they can undergo a therapy called “fecal transplant”. A procedure that today is carried out through a rectal introduction of feces from a "donor" with a healthy intestine.
A pill of…
FDA recently approved VOWST extension, a fecal transplant pill to treat recurring infections from Clostridium difficile. Seres Therapeutics manufactures this pill using properly selected and controlled fecal matter.
The treatment consists of four capsules a day for three days in adults who have already received antibiotics without result.
In a phase 3 study, 88% of patients who took the fecal transplant pill had no recurrence of infection from Clostridium difficile for 8 weeks (I count 60% of the placebo group). Six months after therapy, the 79% of the treated group were still infection-free (vs. 53% of the placebo group).
As bad as that sounds, the availability of a fecal microbiota product that can be taken orally is a major step forward in the care of patients suffering from this life-threatening infection.
Beyond faecal transplantation: new therapies targeting the microbiome
The fecal transplant approach does not stop at a particular bacterial infection. Seres itself is already engaged in a Phase 1b study for its next microbiome-targeting pill, SER-155, intended for people who have undergone organ or stem cell transplants.
The pill contains a blend of lab-grown bacteria designed to inhibit the proliferation of pathogens, reduce intestinal inflammation and modulate the immune system. The target? Prevent antibiotic-resistant infections and Graft-versus-host disease (GvHD), a life-threatening complication in which donated cells attack the recipient's body.
If the pill is successful among transplant patients there could be opportunities to treat cirrhosis, cancer neutropenia and other conditions where antimicrobial resistance is a problem.
More
Other research groups are developing microbiome-targeted therapies to treat cancer, multiple sclerosis, and even aging. Still others seek to identify “biomarkers” in the microbiome that could aid in the diagnosis and prevention of disease. The interesting thing about these therapies is that, unlike our genes, the microbiome can be modified more easily.
From the microbiome a bridge to human health
Before fecal transplantation became the standard for recurrent infections from Clostridium difficile, many people have sought to improve microbiome health with the use of probiotics, “gut-friendly” diets, and other methods, but the effectiveness of these approaches has always been questioned.
Only with the most recent studies are we starting to understand how important the intestinal microbiome is for health, and how we can "manipulate" it to obtain concrete results.
The fecal transplant pill is just the beginning of a new era in medicine, in which our intestine and its ecosystem become protagonists on the path to healing and disease prevention.
