Boston-area nonprofit OpenBiome believes a pill may be the optimal delivery system for fecal transplants
As you may have heard, doctors have been harvesting human waste of late, saving it, and then putting it into someone else’s body.
The recent attention paid to the practice is actually the new part. Fecal matter transplants have been an alternative form of medicine in North America for at least 60 years. But as the technique shows more and more promise in clinical settings, it’s becoming more prevalent.
A fecal transplant is just what it sounds like: By introducing waste from a healthy individual’s digestive system (complete with a complex brew of essential good bacteria) into that of a person who is suffering from the presence of toxic bacteria, it’s possible to rebalance the sick person’s gut microbiome, in many cases leading to their recovery.
Helping push innovation in the field is OpenBiome of Somerville, Massachusetts. Launched in 2012, the not-for-profit’s activities include a stool bank that provides frozen, pre-screened preparations of fecal microbiota for local hospitals – and research projects to advance the field, including a fecal transplant pill that could dramatically ease the difficulties around delivering the treatment.
In a larger sense, says co-founder Carolyn Edelstein, Open Biome’s mission is to support “clinical research to explore the relationship between the bacteria that live in our guts and our health.”
How it works
Experiments with transporting fecal matter from one person to another are known to have happened in ancient China. Modern American accounts of fecal transplants date back to the late 1950s, when stool from healthy individuals was administered via enema to afflicted patients – with good results.
Today the focus of OpenBiome treatments target the clostridium difficile (or c. difficile) infection. The bacterium is one of the major causes of infectious diarrhea worldwide, and it’s the most commonly acquired bug from hospital visits in the United States. The infection is typically treated with a course of antibiotics. The challenge is that antibiotics often prove unsuccessful, or only work temporarily, which can start the patient on a cycle of chronic illness.
Edelstein explains: “In a healthy gut community, c. difficile is out-competed by other bacterial species. However, receiving antibiotic treatment disrupts this ecosystem by killing those protective bacteria.
“C. difficile forms spores that are resistant to antibiotics. No longer outcompeted, this pathogen establishes itself in the gut and produces toxins that leave patients suffering.”
The fecal matter treatment works more like probiotics, fortifying the beneficial gut bacteria to crowd out the nasty c. diff: “With an infusion of bacteria from a healthy donor’s stool, the c. difficile is again out-competed … by repopulating the patient’s microbiome with diverse microorganisms that competitively exclude c. difficile.”
Around half a million North Americans contract c. difficile each year, and it leads to about 30,000 deaths annually in the United States. About 20% of patients who complete a round of antibiotics undergo a relapse anyway. Fecal matter transplant (FMT) treatments have been shown to work at least as well as, if not better than, antibiotics, with a cure rate near 90% when administered via colonoscopy and nasoenteric tubes.
After watching a friend struggle to find access to a much-needed fecal transplant in 2011, a team of MIT and Harvard microbiologists, public health specialists and clinical doctors got together to do something about it. Their friend’s experience brought to light the need for safe and easy access for the service – what North America could use was a “stool bank.”
Today, OpenBiome screens potential donors, stores the samples, freezes and then ships them to hospitals and research facilities for clinical use. Donors are an elite club, subjected to rigorous screening after which fewer than 3% are accepted for future use in fecal transplants. (Who makes a suitable donor? Fit and healthy twentysomethings who only spend time in rich countries.)
OpenBiome credits this strictness, which is far above the norm, for its success in standardizing and popularizing fecal matter treatments in the United States. Since its first treatment in October 2013, the organization has sent more than 18,000 treatments to its network of 800 hospitals.
A frozen preparation at OpenBiome’s fecal matter treatment bank
Being in the Boston area is a benefit, it’s a part of the United States that has a huge medical community thanks to the plethora of local universities that have medical schools – Harvard and UMASS and so on. In addition to having access to some of the best resources and greatest minds in the North American medical community, the location allows important members of the team to participate in nearby conferences to grow their network.
Edelstein says OpenBiome is now supporting 15 active clinical trials researching fecal transplantation in c. difficile and a host of other diseases, “with more in the works.”
Arguably the most noteworthy of OpenBiome’s initiatives is the fecal transplant in pill form, which is intended to make a fecal transplant as easy to administer as antibiotics.
“To present patients with an alternative to some of the more invasive ways of receiving [a transplant], we developed a formulation that could be taken as a pill. It is essentially the same material as patients would receive if they had a colonoscopy or EGD [esophagogastroduodenoscopy]/nasoenteric delivery.”
The pill therapy, which costs $635 ($150 more than other treatment options), remains under development. Despite the ick factor of swallowing a pill incorporating another person’s fecal matter, many patients prefer it over an enema or colon implant, and the risks and difficulties these more invasive procedures entail. “It is easier to take, but our research suggests that it is less effective … than the other two routes of administration, most likely because the capsule is being dissolved in the stomach,” Edelstein says. Whereas 90% of patients respond to the more invasive treatment methods, only 70% recover after taking the pill.
The development of the pill took years of research, and involved technology developed by a group of MIT scientists. The major technological advance was creating a capsule that could hold its integrity for a long time to ensure release of the sensitive material within the proper time after ingestion. (You wouldn’t want it to burst open early.)
In recent years, Western medicine has been reassessing the importance of the microbes that live in our digestive tracts. They impact everything from obesity and heart disease to risk of breast cancer, making gut health an increasingly hot area of medicine.
“We’ve seen the way bacteria help train our immune systems, help us digest our food and protect us from toxins, help send signals to our brains and might even influence our behaviour,” Edelstein says. “We know that our gut microbiota is associated with a host of conditions, and we are working to understand whether microbiota might contribute to those diseases, and how altering the composition of those bacterial communities can change human health.
“As we begin to understand these relationships, we are also learning how to harness these bacterial communities to advance and protect our health. We’ve begun with transfers of whole communities, and in the future, we could also see therapies developed with targeted bacteria that have been identified, isolated, and grown in pure culture, and even the engineering of new microbes.”