Poop pills can fight deadly infections

Editor's note: This article is a reprint. It was originally published on December 11, 2017.

Fecal transplants in capsule form may seem like a bitter pill to swallow, but scientists conducting randomized clinical trials say¹ In other words, these vehicles found that stool therapy was as easy and effective as receiving a stool transplant via enema or colonoscopy, also known as fecal microbiota transplantation (FMT), in treating patients with serious and scary Clostridium difficile infection (RCDI), or simply “C. diff.”

Moreover, FMT in pill form has the potential to improve patients’ quality of life by causing fewer side effects.² For those unfamiliar with the protocol, fecal transplants are no longer uncommon, and one study found that they were so successful that the first trial was stopped early because the researchers deemed it unethical to deny the patients the treatment (some were given alternative therapies, as is customary). As noted by NPR:

“Because C. diff. is kind of a special case. It's a very invasive microbe that's been repeatedly attacked by antibiotics and has other microbes that have been destroyed. So it's an environment that's very susceptible to invasion by microbes from donor stool.”³

C. Diff. — A common bacterium in hospital settings

One of the problems with C. difficile is that it is one of the most common healthcare-associated infections and is one of the biggest reasons hospital patients have debilitating, recurrent diarrhea that is difficult to treat medically. It is especially prevalent in older people who are taking antibiotics for other conditions. CIDRAP says:

“(C. diff.) can be difficult to cure. As a result, recurrent infections have become a growing problem. At least 20% of patients who have had an initial CDI will have a recurrent infection within 8 weeks, and after three or more infections, the risk of RCDI is 50% to 60%.”⁴

Researchers at Brown University, who have a program focused on gut microbes like bacteria, fungi, and viruses (the human microbiome), say C. diff. becomes difficult to manage when antibiotics prescribed for other conditions disrupt the otherwise perfectly functioning benign gut flora. Not a minor infection, Newsweek doesn’t hesitate to call C. diff. both “nasty” and “deadly.”

According to CIDRAP, antibiotics are a common treatment in hospitals, but they effectively wipe out the beneficial bacteria in a patient's community microbiome that suppress C. diff., making the problem worse.

Essentially, FMT can be described as transferring stool from a healthy donor into the gastrointestinal tract of a patient infected with C. diff. The goal is to “reintroduce healthy bacteria into the gut using a non-antibiotic therapy that has been shown to be effective in clinical trials.”⁵

What happens when our gut microbiome is damaged like this?

C. diff. infection affects about 500,000 people in the United States each year. Additionally, according to the U.S. Centers for Disease Control and Prevention (CDC), one in 11 people over the age of 65 who are infected with C. diff will die within a month.⁶

Still, there were patients for whom the prospect of fecal transplantation, even through surgical means, was too daunting. In fact, there were attempts to extract beneficial bacteria from feces to make them more palatable to swallow, but these efforts failed.

While not a completely new and innovative idea, using feces to combat the effects of C. diff. and other problems in patients has been around since at least the late 1950s. In addition to FMT, there are other names for it, including fecal biotherapy and fecal flora reconstitution. One study explains the science behind it.

“FMT involves the reconstitution of the normal gut microbiota of an affected individual by instillation (via nasogastric tube, enema, or colonoscopy) of a liquid suspension of stool from a healthy donor. The first report of the use of FMT (in a patient with non-CDI-like membranous colitis) was published in 1958. Since then, there has been growing evidence to support the use of FMT in recurrent CDI.”⁷

Your microbiome can make or break your health

Scientists are still studying how the microbiome works, especially how it can make or break our overall health. It is clear that certain foods are considered positive for “feeding” the microbiome.

Foods that contain fiber are at the top of the list because they provide nutrients to the gut lining. The connection between what you eat and how healthy your gut is is so closely linked, so consider adding more fiber, especially if you’re not getting the recommended 50 grams of fiber per 1,000 calories.

One way fiber helps your health is by providing the nutrients your gut’s beneficial bacteria need to thrive. These beneficial bacteria help you digest and absorb food, and they play a role in immune function.

One of the best ways to restore optimal balance in your gut is to eat fermented foods. In addition to kimchi and other fermented vegetables that are very easy to make at home, there are also fermented drinks like kefir and yogurt, all of which provide trillions of beneficial bacteria—far more than you can get from a probiotic supplement.

Laxatives, Colonoscopy, or Other Alternatives?

It was a difficult choice for both scientists and doctors. They were trying to decide which protocol was worse: C. diff., antibiotics, colonoscopy (most successful in terms of getting the patient to stool), or the stool pill-popping protocol. C. diff. is serious in its own right and carries with it life-altering symptoms. MedlinePlus⁸ says can include:

Colonoscopy is an example of an invasive procedure, but the fact that the patient is usually under mild sedation, which poses another risk because breathing can become too slow. There is also the possibility that the patient’s bowel wall can be punctured during the procedure, which can lead to life-threatening infections. Observation time:

“The benefits of swallowing a capsule are undeniable compared to swallowing or trying to swallow a feeding tube that leaks stool (which is how doctors testing fecal transplants originally administered the dose).

It carries the risk of aspirating some of the fecal slurry into your lungs, not to mention the unpleasantness of accidentally inhaling feces by putting it in your mouth.”⁹

Poop in a capsule experiment

Dr. Dina Kao, a gastroenterologist at the University of Alberta in Canada, used the pill described in Time magazine.¹⁰ In a trial of 116 patients, “encapsulated stool” was used. Both methods reduced C. diff. recurrences by 90% compared to colonoscopy. All 116 study subjects had at least three previous C. diff. outbreaks and were randomized to receive stool exchange via capsule or colonoscopy.

For patients who had to swallow 40 capsules at a time, it must have been an exercise in “mind over matter.” It took an average of 30 minutes to an hour. The reduction in C. diff. recurrence was confirmed after 90 percent of patients remained C. diff.-free after 12 weeks. Preeti Malani, a professor of medicine at the University of Michigan who wrote an editorial accompanying the study, noted:

“Based on this study, I think it makes perfect sense to consider a fecal transplant capsule as the preferred approach. I think it would be helpful for me or my family to avoid a colonoscopy.”

But Melanie and other researchers believe more research is needed not only to confirm the findings in Kao's study, but also to better understand how fecal transplants work.

Kao himself says he plans to study all the components of the fecal transplant to get a clearer picture of what exactly helps control C. diff. In addition to C. diff, microbiome transplants via capsules are also currently used as treatments for obesity, diabetes, colitis, and Crohn's disease. This is a way in which gut bacteria may be positively linked to lowering the risk of disorders and conditions such as obesity, allergies, asthma, and some mental illnesses.

Fecal transplants offer a less invasive method

A fecal transplant may seem like a huge, botched operation at first glance, but once you understand the process, it becomes clear that it is a successful way to replace bad bacteria with good bacteria.

“This is crazy,” joked Kao, whose first reaction to the successful experiment was, “You don't see this kind of effect with drugs.”¹¹ She added that she believes the favorable results of the fecal transplant drug will “revolutionize” the way conventional medicine thinks about non-traditional treatments. She listed several advantages over current protocols of antibiotics or surgery. The fecal transplant drug:

• Non-invasive
• Less expensive
• There are no risks associated with sedation
• You can do it in your doctor's office

In April 2023, the FDA approved the first “Krabsul,” an oral fecal microbial product called Vowst, to prevent recurrent CDI in adults.¹² In November 2022, the FDA also approved a rectal administration fecal microbial product, live-jslm (trade name Rebyota).¹³ Both of these microbial-based drugs are known as living biotherapeutics, or LBPs. According to the Gut Microbes review:¹⁴

“LBP does not have antibacterial activity against C. difficile, so it does not shorten the time to initial clinical treatment or increase overall cure rates. Instead, it is intended to reduce the likelihood of relapse by restoring a healthy microbiota balance.”

FMT and other forms of fecal therapy have shown promise in improving gut health for liver disease, C. diff, and other health conditions. However, prevention is still the best strategy, so it is very important to support gut health regularly through a healthy lifestyle.