World’s first pill made from human feces

It’s done! Scientists have finally learned how to make not a candy, but immediately a pill from natural human excrement. The first human waste-based drug has been approved by the U.S. Food and Drug Administration (FDA). The world’s first oral therapy based on fecal microbiota is designed to treat recurrent infections with the bacterium Clostridioides difficile.

The drug, which is based on donor human feces, is the first in the history of pharmacology. Although fecal therapy itself has been known in the world for a long time and causes a lot of controversy. A patient with certain gastrointestinal problems is transplanted with the microbiota (intestinal contents) of a healthy person as his own microbiota normalizes. For the first time, such a method of treatment was mentioned back in the 4th century: in China, patients who suffered from severe diarrhea were prescribed “yellow soup”. In our time, as the head of the endoscopy department of the Clinical Hospital No. 2 of the First Moscow State Medical University named after I.M. Sechenov Pavel Pavlov, in the medical literature in 1958 for the first time described the successful treatment of pseudomembranous (clostridial) colitis by fecal microflora transplantation (FMT): “The American FDA approved FMT for the treatment of recurrent or antibiotic-resistant clostridial colitis in 2013, and in Europe this happened in 2017. Since then, the victorious march of the method across the planet has begun.

Now everything is simplified to a pill, which does not require invasive interventions. So far, the drug is intended only for adults (from 18 years of age), but it may eventually receive approval for pediatric practice. Treatment is approved only for infections caused by the bacterium Clostridioides difficile that resolve in a recurrent mode.

Most often, such infections develop in patients receiving antibiotic therapy in hospitals. It is believed that taking antibiotics disrupts the balance of the intestinal microflora, which creates favorable conditions for the reproduction of this pathogenic bacterium. It releases toxins, which leads to general intoxication of the body and the appearance of symptoms such as abdominal pain, diarrhea. All this does not pass harmlessly: in a number of patients, such infection leads to inflammatory bowel diseases (pseudomembranous colitis), which periodically causes relapses. Well, in some cases, the Clostridioides difficile bacterium even causes death. Every year, from 15 to 30 thousand people die for this reason in the United States alone.

By the way, in Russia, doctors recorded a surge in the incidence of pseudomembranous colitis in the first year of the pandemic, when patients with severe forms of covid were literally stuffed with various types of antibiotics.

Until now, one of the main methods of treating Clostridioides difficile has been … also antibiotics, however, only a certain group. Because it is resistant to most known antibiotics. However, most often the infection becomes chronic: after some time after the removal of symptoms, the disease recurs. The patient is again prescribed antibiotics, which further upsets the balance of the intestinal microflora. The new capsule, based on donor feces from a healthy person, is promised not to cause relapses of pseudomembranous colitis. The medicine not only stops the reproduction of Clostridium, but also saturates the microbiome with beneficial microorganisms.

And although the microflora of donors is carefully checked for the manufacture of the tablet, a small risk of infection with pathogens remains. As well as the transfer of allergens (in case the donor has eaten some product that the recipient is allergic to). Experts call this method of treatment not the most pleasant from an aesthetic point of view, but it gives hope to people with a serious illness.

As pharmacologist Yuri Kiselev says in his social network, the microbiome is a collection of microorganisms that more or less constantly live in a specific area of ​​​​our body: “The microbiome does not just passively live on us like on a lawn, it releases a huge amount of substances like a giant biofactory. If we talk about the large intestine, these molecules are often small in size, allowing them not only to influence the condition of the intestinal mucosa, but also to penetrate deep into and spread throughout the body with the bloodstream, potentially affecting all organs and functions of the body. In fact, this biofactory is an independent body!

Scientific studies over the past 20-30 years have shown that changes in the colon microbiome are somehow associated with dozens of diseases, from allergies and depression to ulcerative colitis and arthritis. What’s more, the microbiome also influences the medications we take.”

The expert emphasizes that so far in the world “no preparations of probiotics (live microorganisms) or prebiotics (“fertilizers” for the microbiome, such as inulin) have convincing evidence. However, in the treatment of chronic clostridial diarrhea – a debilitating, severe disease – success has been achieved through fecal transplantation of the contents of the large intestine of a healthy person into the intestine of a sick person. Yuri Kiselev also talks about one of the latest studies, when a gene is inserted into a patient’s E. coli to produce something useful (even a drug), and returned back: “This is how we get our own pharmaceutical production in our own intestines.”

…In Russia, a new fecal capsule has not yet been registered, and the method of fecal transplantation is not even in the “Procedures for the provision of medical care” of the Ministry of Health of the Russian Federation. But it is still used in research institutions as an experimental treatment for the most difficult patients who have not been helped by long courses of antibiotics. According to Dr. Pavlov, the method demonstrates high efficiency in the treatment of recurrent clostridial colitis. If fecal preparations appear in Russia that do not require “dancing with tambourines” (that is, special transplant procedures), the life of our patients will be significantly simplified.

…Meanwhile, researchers believe that more than 50 specific disorders and diseases can be treated with the help of the microbiome, including diabetes mellitus, inflammatory bowel disease, atherosclerosis, dermatitis, asthma, and colorectal cancer. Various studies show that microbiome-based medical solutions have the potential to positively impact all aspects of human health and help heal people around the world. Scientists are inspired by the limitless possibilities that the microbiome provides for the prediction, diagnosis and treatment of many diseases.