There’s no way around it, so I’ll be direct. The FDA has given the green light to a very special pill made of human fecal matter to fight bacterial infections in the intestines. The “fecal transplant” pill, developed by Seres Therapeuticscould open up a world of possibilities for treating different diseases simply by targeting our microbiome.
The CEO of the company, Eric Shaff, did not hesitate to call it “a pivotal moment for the sector”. I dare not 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 “gut microbiome”. While it may seem creepy, these little guests are mostly harmless and often useful: 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 depression to cancer and stroke. A delicate ecosystem that can be affected by many factors, including diet, ancestry, medications and even our social environment.
The “faecal transplant” as a treatment tool
The infection from Clostridium difficile it’s 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 the bacteria that compete with the Clostridium difficile for resources.
To help restore balance, people with severe or recurring 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…
The FDA recently approved VOWSTa fecal transplant pill to treat recurring infections from Clostridium difficile. Seres Therapeutics manufactures this pill using carefully selected and controlled faecal 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, il 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 faecal transplant approach does not stop at a particular bacterial infection. Seres itself is already engaged in a Phase 1b study of 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 the 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.
Still
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 disease diagnosis and prevention. The interesting thing about these therapies is that, unlike our genes, the microbiome can be changed more easily.
From the microbiome a bridge to human health
Before fecal transplantation became the standard for recurrent infections from Clostridium difficileMany people have tried 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 faecal transplant pill is just the beginning of a new era in medicine, in which our intestine and its ecosystem become protagonists in the path towards healing and disease prevention.