You may not think eating poop seems like a good idea, but it’s actually an emerging, and even popular, wellness trend.
Yes, the new frontier of gut health craze involves taking pills that contain other people’s fecal matter.
So-called “fecal microbiota transplants,” which are said to cure life-threatening digestive infections and relieve common ailments such as constipation, have emerged from the laboratory and are now available for use at home.
Companies that offer the service take “healthy” poop (containing gut-stimulating bacteria) from a donor and process it into a pill.
One company, Human Microbes, offers $100 Poop Enemas and $10 Poop Pills which could “potentially treat” everything from irritable bowel syndrome to diabetes and Alzheimer’s.
However, experts have warned that there are serious risks associated with this strange drug, including life-threatening infections.
This is an example of what FMT looks like in the form of an enema or colonoscopy when used in a hospital.
Potentially unpleasant germs may be hidden in the donor sample and, due to the lack of regulation, remain hidden, easily infecting the patient who ingests it.
Dr. Vincent B. Youngprofessor of infectious diseases at the University of Michigan, told the Daily Mail: “There are risks in giving feces to someone, as you are giving them all kinds of bacteria that could include a pathogen.”
‘If the poop product is not properly examined, you can open it [the recipient] to many other diseases for which they had no risk.’
This includes pneumonia, E. coli, monkeypox, COVID and Ebolato name a few.
In fact, a patient who underwent an experimental treatment with FMT, to treat a stem cell transplant gone wrong, died in 2019 after being implanted with a sample containing an antibiotic-resistant strain of E. coli.
Despite this, the FDA approved the first-of-its-kind treatment last year, fueling the fire of at-home fecal transplant fans, who have gained popularity online for documenting their stool supplement regimen.
Now, health officials have raised the alarm about a company that buys and sells excrement and FMT products.
Human Microbes claims its products, made from its pool of poop “super donors,” could help you cure your ailments in the comfort of your home.
But the US Food and Drug Administration (FDA) has issued a stern warning against Human Microbes, citing that its products are unregulated and make false claims that could harm consumers.
The FDA letter said the company’s products are not sufficiently tested before being sold to customers and therefore pose “significant safety concerns.”
Human Microbes products are made by taking “healthy” donor poop, mixing it with saline and thickeners like maltodextrin, and putting it into capsules or enemas, Human Microbes shared in a company. Youtube video.
The FDA-approved FMT treatment, called Rebyota, is made from excrement, but its manufacturing process is done in a laboratory, regulated by the FDA, and is sold by prescription to be used under medical supervision. Human Microbes products are available for purchase outside of that structure.
‘Human Microbes provides the ingredients so you can perform FMT yourself with your doctor’s supervision,’ their website read. ‘FMT has generally been performed as a medical procedure in a hospital. But since you can get better results and lower costs from the comfort of your home, that seems like the optimal option.”
Michael Harrop, founder of Human Microbes, who appears in a promotional video on the company’s YouTube.
For Human Microbes to continue selling products, they would have to go through the FDA regulatory process or remove mention of fecal microbiota transplantation (FMT) from their website, company founder Michael Harrop told the Daily Mail via email. electronic.
Such oversight would disrupt Harrop’s mission of providing a widely available pool of poop donors to the public who, like him, may be seeking FMT treatments to treat a range of conditions, he said.
Harrop said the current FDA guidelines are “very restrictive and possibly inappropriate for the FMT and the human microbes project.” If they insist, they will probably kill this project.”
But other experts in the FMT world say these barriers exist for good reason. “Safety is absolutely paramount when testing these biologics,” said Herve Affagard, founder of microbiome therapeutics company Maat Pharma.
“I don’t know why regulators wouldn’t be involved,” Affgard continued.
Testing is very important because a “good sample” not only contains a diverse set of bacteria, but also must be screened for a flood of potential infectants, Dr. Young said.
This includes drug-resistant bacteria, such as E-coli, which caused the patient’s death in 2019. She also needs to be tested for viruses and common bugs such as monkeypox and COVID-19both discovered alive in poop samples.
A doctor demonstrates what one of the FMT products they can use in the hospital looks like.
In controlled settings, when all tests are done correctly, fecal transplantation has been like a miracle therapy: curing near-death patients with drug-resistant infections and sepsis.
But FMT therapy has only been conclusively shown to help cure one type of infection, caused by a bacteria called Clostridium difficile (C. diff), said Dr. Young, who studies FMT.
The bacteria infects approximately 500,000 people in the US each year, and kills about 30,000 people, according to Yale researchers. If your gut is healthy, your system is probably strong enough to defend itself against serious illnesses, Dr. Young said.
But if your intestine is weakened due to previous hospitalizations, antibiotics, or surgery, there is a chance that a C. diff infection could lead to life-threatening conditions, such as sepsis.
Despite this, Harrop wrote that he believes “FMT may come close to being a panacea with a good enough donor.”
Gut microbiome research has been incredibly popular in recent years.
This is consistent with Human Microbes’ online advertising, which the FDA letter claims is misleading, and implies that FMT may be a treatment for a wide variety of ailments, including: irritable bowel syndrome, inflammatory bowel disease , Parkinson’s, fibromyalgia, chronic fatigue, multiple sclerosis, autism, diabetes, depression, obesity, autoimmunity, cardiovascular diseases, cancer, anxiety and bipolar disorder.
Human Microbes notes on its website that its screening practices are “in line with international guidelines,” but the FDA letter states that screening and processing of stool is typically done under the supervision of a licensed health care provider. .
Harrop is the company’s only employee and is not a healthcare provider. His last formal education was in high school.
In several blog posts responding to the FDA’s letter, Harrop stated that the only problem with the company’s product is that there simply isn’t enough of it; He said his company has not been able to find “high-quality feces.” that qualifies to be converted into their products.
Other brands, such as Affagard’s Maat Pharma, have reported no problems finding suitable donors to manufacture FMT products.
Affagard told the Daily Mail that its supply chain is consistent, complies with European governing bodies and is on track to gain approval for mass use by 2026.
Each person’s gut microbiome is unique, making it difficult to determine what a “good” microbiome is.
The rally in FMT-based companies comes amid rabid popular fascination with the gut microbiome as the source of all of man’s woes.
But much of the science in this area is new, and many products, such as at-home gut microbiome tests, have therefore been proven false.
This is because each person has a different colony of bacteria that is personal to them, Affgard explained. Everything you’ve done in your life has contributed to the colony of bacteria living in your body, from whether you were born by C-section to whether you decided to have a drink last weekend.
Therefore, there is currently no scientific agreement on what constitutes a “good” gut microbiome and a “bad microbiome.”
As researchers continue to explore the possible applications of feces through slow but careful scientific exploration, they may discover that FMT has applications beyond the treatment of C diff.
But in the meantime, Dr. Young said guidelines from organizations like the FDA are there to “protect people from selling political snake oil, basically.”
The FDA declined to comment on its letter.