By Gabrielle Emanuel
Fecal transplants may have just gotten a lot easier to swallow.
OpenBiome, the nation’s first stool bank, is beginning large-scale production of a poop pill. This week marks the first time such a pill will be commercially available to hospitals and clinics.
Early tests suggest the pill is highly effective and comparable to traditional, more invasive delivery methods — for instance via colonoscopy, enema or a plastic tube through the nose and into the stomach or intestines.
“Fecal transplants came from what used to be this dark art — where you needed a donor and a blender,” says Mark Smith, research director at OpenBiome and one of its founders. “And now you basically take something out of the freezer and can treat the patient immediately. I’m very, very excited about this.”
Try not to get grossed out because this is an upbeat story. It’s about a very effective medical treatment for a really nasty infection.
Earlier, we reported on fecal transplants and OpenBiome’s struggle to survive.
Founded by MIT students and based in Medford, OpenBiome is just like a blood bank but for poop.
“Fecal transplants came from what used to be this dark art — where you needed a donor and a blender. Now you basically take something out of the freezer and can treat the patient immediately.”
It collects healthy poop and then gives it to doctors so they can perform fecal transplants. This procedure is used for patients with recurrent Clostridium difficile or C.diff infections. The bacterium is in the gut and can cause bad — sometimes debilitating — diarrhea.
C.diff sickens hundreds of thousands each year and kills nearly 30,000 people annually in the U.S.
But fecal transplants have proven to be remarkably effective when it comes to C.diff. Technically called Fecal Microbiota Transplantation (FMT), the procedure has been shown to be nearly 90 percent effective in treating C.diff. That’s compared to standard antibiotics, which cure less than 40 percent of recurrent C.diff patients, according to OpenBiome.
This procedure involves collecting stool from a healthy donor and infusing it in the gut of a sick individual. But the catch is that the delivery method is both unpleasant and invasive.
It’s often done through a colonoscopy or an enema. And sometimes it’s delivered through a tube that goes in the nose and all the way in to a person’s stomach or gut. These are involved, not-too-pleasant procedures that carry their own risks.
That’s why OpenBiome’s pill announcement is a big deal. It suggests there may be a much easier and far less invasive way to carry out fecal transplants: Just get a glass of water and swallow a pill.
“And [patients] usually will recover very quickly — within a couple days,” Smith says.
At this point, though, it does take more than just one pill. A dose is 30 large pills swallowed in a short period of time — usually within an hour and a half after removal from the freezer — and always in the presence of a doctor or nurse.
Inside the pills, called FMT Capsule G3s, are all the good bacteria in a concentrated form.
One dose of 30 pills costs $635. That’s compared to $385 for the colonoscopy and nose delivery method. OpenBiome says it sells everything at costs with no markups. So, they say, the cost difference reflects how much harder it is to make the pills.
“Right now, each one is made by hand,” Smith says. “We have an army of technicians that are making capsules every day.”
They’re hoping they’ll soon be able to automate the process and make it cheaper.
A pilot study suggests the pills are 70 percent effective with the first dose, according to OpenBiome. And if that doesn’t do the trick, the patient gets a second dose. After the second dose, the cure rate jumps to 94 percent. And they haven’t found any nasty side effects or problems yet.
“This adds a whole new dimension to the treatment,” says Dr. Lawrence Brandt, a professor at Albert Einstein College of Medicine in New York and a chief emeritus of gastroenterology at Montefiore Medical Center. “I think it’s a game changer in terms of the availability, making this a much more widespread treatment.”
Dr. Brandt has been performing fecal transplants since 1998 but he says the pill will likely change his practice. He says until now other doctors have sent him patients who need fecal transplants. He expects the pill means he’ll get fewer referrals.
“The number of people who can do endoscopic procedures is limited — it’s a big number but it’s limited. The number of doctors who can write a prescription for a pill is vast,” Dr. Brandt says. “But I don’t care if they don’t send me the patients. I’m not interested in the volume of patients. I am interested in seeing patients who need my help because nobody else can help them.”
A pill seems like a highly logical solution. But it didn’t exist until now because it’s actually a challenging thing to produce.
“Most of the capsules we have to deliver drugs are made to dissolve when they’re in poo,” Smith says.
Basically, inside the pill is good bacteria and it thinks its job is to break down food and really anything that comes its way — including the capsule walls. In addition, poop is fairly watery and capsules are designed to dissolve in water. Because of this, the pill would only last a few minutes before the poop dissolved the capsule walls.
Many scientists have been trying to figure out what to do about this. After about a year and a half of work and testing, researchers at OpenBiome came up with something they’re calling the Microbial Emulsion Matrix (MEM).
Basically they’re taking the poop and suspending it in oil. The oil prevents the water from dissolving the capsule. Then, they freeze the capsule. This doesn’t kill the bacteria but it does make them inactive, stopping them from breaking down the capsule. Only once the pill is inside the gut does it break down — this time from bacteria on the outside, instead of on the inside.
Smith says this is exciting, not just for C.diff patients. “This enables some studies to happen that couldn’t happen otherwise.”
He’s particularly interested in finding out whether fecal transplants could be used to treat chronic GI issues, including Inflammatory Bowel Disease and Irritable Bowel Syndrome. These chronic problems would require regular fecal transplants — maybe once a week or even every day.
“If you had to do a colonoscopy every day, you’d never enroll in a study,” says Smith. “But if you have to just take a capsule, it’s pretty reasonable.”
Smith warns this is all in a very early stage but still, he says, in the world of fecal treatment, it’s a big milestone.
This post was updated at 11:30 a.m. with Dr. Brandt’s comments.
Gabrielle Emanuel, a former WBUR Kroc Fellow, now works as an education reporter for NPR in Ann Arbor, Michigan.