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 sounds like a good idea, but it is in fact an emerging - and even popular - wellness trend.

Yes, the new frontier of the gut health craze involves taking pills that contain other people's fecal matter.

Said to both cure potentially deadly digestive infections and ease common complaints like constipation, so-called 'fecal microbiota transplants' have emerged out of the lab and are now available to use at home.

Companies offering the service take 'healthy' poop - containing gut-boosting bugs - from a donor and process it into a pill. 

One firm, Human Microbes, offers 100 dollar poop enemas and 10 dollar poop pills that could 'potentially treat' everything from IBS to diabetes to Alzheimers. 

However, experts have warned that there are serious risks linked to the bizarre medication - including potentially deadly infections. 

This is an example of what FMT in an enema or colonoscopy form looks like when used in a hospital setting

Potentially nasty germs may be lurking in the donors' specimen and, due to a lack of regulation, remain hidden, easily infecting the patient who ingests it. 

Dr Vincent B. Young, a professor of infectious diseases at the University of Michigan, told the Daily Mail: 'There are risks to giving feces to someone, as you're giving all sorts of bacteria which could include a pathogen.

'If the poop product isn't properly screened, you could, open them [the recipient] up to many other diseases that they didn't have a risk for.'

This includes pneumonia, E coli, monkey pox, COVID and Ebola, to name a few.

Indeed, one patient who underwent an experimental treatment with FMT - to treat a stem cell transplant gone wrong - in 2019 died after he was implanted with a a sample that contained 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 fanatics, who have gained popularity online for documenting their poo supplement regimen. 

Now, health officials have raised the alarm about a company buying and selling poop and FMT products.  

Human Microbes claims that its products, manufactured from its pool of poop 'super-donors', might help you cure your ailments in the comfort of your own home.

But the US Food and Drug Administration (FDA) has issued a stark warning against Human Microbes, citing that their products aren't regulated and they make false claims that could harm consumers. 

The FDA's letter said that the company's products are not sufficiently screened before being sold to customers and therefore represent '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 on a company YouTube video. 

The FDA approved FMT treatment, called Rebyota, is made from poop, but their manufacturing process is done in a lab, regulated by the FDA and 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 for you to DIY FMT with oversight from your doctor,' its website reads. 'FMT has generally been done as a medical procedure in a hospital. But since you can get better results and lower costs from the comfort of your own home that seems like the optimal choice.'

Michael Harrop, the founder of Human Microbes, appearing in a promotional video on the company's YouTube

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

This oversight would disrupt Harrop's mission to provide a widely available pool of poop donors to the public, who like him, may be seeking FMT treatments to treat a host of conditions, he said. 

Harrop said the FDA's current guidelines are, 'very restrictive and arguably inappropriate for FMT and the Human Microbes project. If they insist, it will likely kill this project.'

But other experts in the world of FMT say that these guardrails are in place for good reason. 'Safety is absolutely paramount in testing these biologics,' Herve Affagard, the founder of microbiome therapeutics company, Maat Pharma, said. 

'I don't know why the regulators wouldn't be involved,' Affgard followed.

Testing is so important because a 'good sample' not only contains a diverse set of bacteria, but it also needs to be screened for a barrage of potential infectors, Dr Young said. 

This includes drug resistant bacterium, like the E-coli, that led to the death of the patient in 2019. It also needs to be screened for common viruses and bugs like monkey pox and COVID, which have both been discovered alive in samples of poo. 

A doctor demonstrating what one of the FMT products that they may use in the hospital looks like

In controlled scenario's, when all the testing is done correctly, fecal transplant has been like a miracle therapy- curing patients on deaths doorstep with drug resistant infections and sepsis. 

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

The bacterium infects roughly 500,000 people in the US each year, and kills an estimated 30,000, according to Yale researchers. If your gut is healthy, your system is probably strong enough to fend off serious illness, Dr Young said. 

But if your gut is weakened, from previous hospital stays, antibiotics or surgery, then there is a chance a C. diff infection can lead to life threatening conditions like sepsis. 

Despite this, Harrop wrote that he believes 'FMT may be close to a panacea with a good enough donor.' 

Gut microbiome research has been incredibly popular in recent years

That is consistent with Human Microbes online advertising, which the FDA letter states is misleading, and implies that FMT may be a treatment for a huge swath of ailments, including: irritable bowel syndrome, inflammatory bowel disease, Parkinson's, 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 poop screening and processing is normally done under the supervision of a licensed health care provider. 

Harrop is the sole employee of the company, and is not a health care 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 hasn't been able to find 'high-quality stool' that qualifies to be made into their products.  

Other brands, like Affagard's Maat Pharma, have reported no issues finding appropriate donors to make FMT products. 

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

Each person's gut microbiome is unique, which makes it difficult to determine what a 'good' microbiome is

The uptick in FMT based companies comes amid a rabid popular fascination with the gut microbiome as a source for all ails of man. 

But a lot of the science within this realm is new, and thus, many products, like at home gut-microbiome tests, have been shown to be duds.  

That's because each person has a distinct colony of bacteria that is personal to them, Affgard explained. Everything you've done in your life has contributed to the colony of bacterium that live in your body- from whether you were delivered by C-section to if you decided to have a drink last weekend. 

So there is not a current scientific agreement on what constitutes a 'good' gut microbiome and a 'bad microbiome'. 

As researchers continue exploring the potential applications for poop through slow, but careful scientific exploration, they may discover that FMT has applications outside of treating C diff. 

But in the meantime, Dr Young said guidelines from organizations like the FDA are there to, 'protect people so that people aren't selling political snake oil, basically. 

The FDA declined to comment on its letter.