FDA warning over ‘gut-boosting’ pills that contain other people’s POOP, amid links to deadly bacterial infections

You might not think that eating poop seems like a good idea, but it’s actually an emerging – and even popular – wellness trend.

Yes, the next frontier of the gut health craze is taking pills that contain other people’s feces.

They are said to cure potentially fatal digestive infections and relieve common complaints such as constipation. So-called ‘fecal microbiota transplants’ have emerged from the laboratory and are now available for home use.

Companies offering this service take “healthy” poop – which contains intestinal-helping insects – from a donor and process it into a pill.

One company, Human Microbes, offers $100 poop enemas and $10 poop pills that could ‘potentially’ treat everything from IBS to diabetes and Alzheimer’s.

However, experts have warned that there are serious risks associated with the bizarre medication, including potentially fatal infections.

Potentially nasty germs can lurk in the donor’s sample and, due to a lack of regulation, remain hidden, easily infecting the patient who takes it.

Dr. Vincent B. Younga professor of infectious diseases at the University of Michigan, told the Daily Mail: ‘There are risks associated with giving feces to someone because you are giving all kinds of bacteria that could contain a pathogen.

“If the poop product is not properly screened, you can expose them (the recipient) to many other diseases that they are not at risk for.”

This includes pneumonia, E coli, monkeypox, COVID and Ebolato name a few.

One patient indeed who underwent experimental treatment with FMT – to treat a failed stem cell transplant – died in 2019 after he was implanted with a sample containing an antibiotic-resistant strain of E Coli.

Despite this, the FDA approved the first treatment of its kind last year, fueling the fire of at-home fecal transplant fanatics who have become popular online for documenting their poop supplement regimen.

Now health officials have raised the alarm about a company that buys and sells poop and FMT products.

Human Microbes claims that its products, crafted from the poop super donors, can help you cure your ailments in the comfort of your own home.

But the US Food and Drug Administration (FDA) has made a decision a sharp warning against Human Microbes, alleging that their products are unregulated and that they make false claims that could harm consumers.

The FDA letter states that the company’s products are not adequately screened before being sold to customers and therefore pose “significant safety concerns.”

Human Microbes products are made by taking “healthy” donor poop, mixing it with a saline solution and thickeners such as maltodextrin, and putting it into capsules or enemas, Human Microbes told a company Youtube video.

The FDA-approved FMT treatment, called Rebyota, is made from poop, but the manufacturing process is done in a laboratory, regulated by the FDA and sold by prescription for use under medical supervision. Human Microbes products are available for purchase outside this structure.

“Human Microbes supplies the ingredients with which you can make FMT yourself, under the supervision of your doctor,” the website says is reading. ‘FMT is generally performed as a medical procedure in a hospital. But because you can achieve better results and lower costs from the comfort of your home, that seems to be the optimal choice.’

In order to continue selling Human Microbes products, they would have to go through the FDA’s regulatory process, or remove mention of fecal microbiota transplantation (FMT) from the website, company founder Michael Harrop told the Daily by email Mail.

This oversight would disrupt Harrop’s mission to provide a widely available pool of poop donors to the public, who like him are seeking FMT treatments to treat a wide range of conditions, he said.

Harrop said the FDA’s current guidelines are “highly restrictive and demonstrably inappropriate for FMT and the Human Microbes Project.” If they continue to insist, this project will likely be doomed.”

But other experts in the FMT world say these guardrails are put in place for a reason. “Safety is absolutely paramount when testing these biologics,” says Herve Affagard, the founder of microbiome therapeutics company Maat Pharma.

“I don’t know why the regulators wouldn’t be involved,” Affgard continued.

Testing is so important because a “good sample” not only contains a diverse range of bacteria, but must also be screened for a barrage of potential infectors, Dr. Young said.

This also applies to drug-resistant bacteria, such as E-coli, which led to patient death in 2019. It should also be screened for common viruses and insects such as monkeypox And COVIDboth of which were discovered alive in fecal samples.

In controlled scenarios, if all testing is done correctly, fecal transplantation has proven to be a miracle therapy: curing patients who were on the verge of death due to drug-resistant infections and sepsis.

But FMT therapy has only been conclusively shown to help clear one type of infection, caused by a bacteria called Clostridium difficile (C. diff), said Dr. Young, who studies FMT.

The bacteria infects about 500,000 people in the US each year kills an estimated 30,000 people, according to Yale researchers. If your gut is healthy, your system is likely strong enough to ward off serious illness, Dr. Young said.

But if your intestines are weakened due to previous hospitalizations, antibiotics, or surgery, there’s a chance that a C. diff infection could lead to life-threatening conditions like sepsis.

Nevertheless, Harrop wrote that he believes that “FMT with a good enough donor can almost be a miracle cure.”

That’s consistent with Human Microbes’ online advertising, which the FDA letter says is misleading and implies that FMT can be a treatment for a variety of conditions, including: irritable bowel syndrome, inflammatory bowel disease, Parkinson’s disease, fibromyalgia, chronic fatigue, multiple sclerosis, autism, diabetes, depression, obesity, autoimmunity, cardiovascular disease, 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 fecal screening and processing is normally performed under the supervision of a licensed healthcare provider.

Harrop is the company’s sole employee and is not a healthcare provider. His last formal education was in high school.

In multiple blog posts in response to the FDA’s letter, Harrop has stated that the only problem with the company’s product is that there simply isn’t enough of it — he said his company has failed to deliver “high-quality stool.” find. that are eligible to be incorporated into their products.

Other brands, such as Affagard’s Maat Pharma, have reported no problems finding suitable donors to make FMT products.

Affagard told the Daily Mail that their supply chain is consistent, compliant with European governing bodies and on track to be approved for mass use in 2026.

The revival among FMT-based companies comes amid a rabid popular fascination with the gut microbiome as the source of all human ailments.

But much of the science in this area is new, which is why many products, such as at-home gut microbiome tests, have been shown to be fake.

That’s because each person has a separate colony of bacteria that is personal to him or her, Affgard explained. Everything you’ve done in your life has contributed to the colony of bacteria living in your body – from the moment you gave birth by caesarean section to the moment you decided to have a drink last weekend.

So there is currently no scientific agreement about what constitutes a ‘good’ gut microbiome and a ‘bad microbiome’.

As researchers continue to explore the potential uses for poop through slow but careful scientific research, they may discover that FMT has applications beyond treating C diff.

But in the meantime, Dr. Young says, there are guidelines from organizations like the FDA to “protect people, so people aren’t actually selling political snake oil.”

The FDA declined to comment on its letter.