Her son had been sick for four months when Blanca Morales started asking about a transplant. It had started with a case of strep throat from Mundo’s first-grade class — routine enough, treatable with antibiotics. Then he started having stomach trouble. Mundo was the youngest of five. Morales had been a mom a long time. She wasn’t fazed by a little vomiting. She kept pails from Halloween and Easter by her kids’ beds, just in case. This was routine until it wasn’t. Morales sat on the floor by the toilet pinning back Mundo’s hair, catching his throw-up in a bucket, wiping his tears. They wound up at the ER.
Morales had never heard of Clostridioides difficile when they got the diagnosis. By the third relapse, she could identify the infection by its smell. It was both acrid and sweet at once, somewhere between burnt plastic and rotting flower, the smell of hospital. The illness had likely been sparked by strep-fighting antibiotics back in March 2025, the bacterial community of Mundo’s colon wiped out, allowing the heartier, toxin-spewing C. diff to proliferate — a microscopic strongman taking advantage of a microbial power vacuum.
In April, Mundo had learned to take pills so he wouldn’t have to get C.-diff-targeting antibiotics by “pokey,” as he called the IV he’d gotten when he first arrived at the hospital, one nurse trying to get it into his arm and two others holding him down. Then it was July. Mundo had tried three courses of various drugs. Three times his bloody diarrhea disappeared a few days after he started the medication. Three times it came back once he stopped. Morales wanted to try something else.
The transplant she was asking about didn’t involve an organ or tissue, but a whole microbial world, taken from one person’s gut and seeded in someone else’s. More colloquially, it was therapy made of poop. Known as a fecal microbiota transplant, or FMT, the idea was to restore a diverse ecosystem and reintroduce bacterial competition, so C. diff no longer had the run of the place. But as commonplace as the basic ingredient might’ve been — it was literally waste, flushed out of sight and out of mind — the antidote itself had become harder to find.
At the end of 2024, the Food and Drug Administration had halted shipments from a major supplier of fecal transplant material, a national stool bank called OpenBiome. That left kids like Mundo with fewer options. “It shouldn’t be this hard to cure a child,” Morales said.
It was partially a question of geography. Morales and Mundo live in Las Vegas. If he’d gotten sick a year earlier, he might have gotten this treatment within a few miles of his house, care of OpenBiome, which had since 2013 been sending human feces — screened for pathogens, food particles filtered out — to hospitals nationwide, including 17 sites in Nevada. But then in 2022 and 2023, two companies secured FDA approval for human-excrement-derived drugs to prevent C. diff. recurrence. “The FDA said to us, ‘time to wrap up,’” said Julie O’Brien, CEO of what’s now the OpenBiome Foundation.
To federal officials at the time, the change closed a potentially dangerous and unfair loophole, no longer allowing a nonprofit to send swirls of semi-regulated microorganisms into patients’ digestive tracts once there were regulated alternatives. But the two drugs weren’t approved for kids, the immunocompromised, or those whose C. diff is severe.
They were also expensive, often far more than a transplant. According to First Databank, Vowst’s list price is $19,680 for 12 pills and Rebyota’s is $9,411 for one enema bag. Insurers sometimes balked at covering them even for the intended patients. The denials were only more vociferous at the idea of using them off-label for someone like Mundo. An FDA approval was supposed to protect patients — and in theory, make effective treatments more accessible. In the real businessy world of American health care, that wasn’t always how it worked out.
A whiff of the DIY
When a colleague first called Neil Stollman in 2004 and asked him if he’d perform a fecal microbiota transplant on a C. diff patient named Rose, he laughed. He was a gastroenterologist in private practice in Oakland, Calif., scoping people’s colons, probing the mysteries of their bowel movements. He was used to the wrinkle-nosed reaction to his line of work, but this request was wrinklier than most. The hypothesis, though, made sense.
“I allowed that plausible biology to supersede my own ick,” Stollman recalled. “We figured out how to make sort of a milkshake out of it and put it inside Rose. I don’t want to sound hyperbolic, but it was pretty impressive. Rose was sick, Rose got better, and all I did was, you know, put some poop up her tush.”
The idea had been around for millennia. A 4th century Chinese handbook for emergency medicine described feeding gastrointestinal-disease patients a fecal suspension and watching them return from the brink of death. Case reports from the mid-20th century credited it with saving lives. Stollman was hardly the only physician involved in the revival. In 2008, when University of Minnesota gastroenterologist Alexander Khoruts gave an FMT to one patient, he not only got rid of her C. diff — previously so severe she needed a wheelchair and diapers — but also used before-and-after DNA sequencing to show a microbial ecosystem restored.
But even as it entered the arsenal of modern medicine, FMT still had a whiff of the DIY: doctors and their blenders, making one bespoke slurry at a time.
Then came OpenBiome. A microbiology grad student at Massachusetts Institute of Technology had watched a friend struggle with C. diff for over a year, unable to kick the infection after seven courses of the heavy-duty antibiotic vancomycin; he ended up soliciting a roommate’s dung and giving himself an FMT at home. There has to be a better way, thought the grad student — and the thought became a nonprofit, like a blood bank for stool.
The idea, inspired by Khoruts’ protocols, was to streamline and standardize what had previously been a patchwork. Physicians had been making sure their transplants weren’t transmitting HIV or hepatitis C, but a consolidated operation could screen for more pathogens and be pickier about its donors. It lowered the barrier to entry. Doctors could order FMTs without crafting the things themselves. In 2013, Stollman became the first to use a shipment from OpenBiome — and over the next decade, the bank sent some 72,000 treatments to more than 1,300 hospitals and clinics.
Initially, FDA officials had balked at such unapproved material. But many patients, unable to get relief from antibiotics, had little else to try. Some 15,000 Americans were dying of C. diff every year — and the data for FMT looked remarkable. That year, a trial comparing the transplant to vancomycin had to be stopped early: Less than a third of those on the antibiotic recovered, while 81% of the FMT recipients did after one dose, which jumped to 94% with the inclusion of those who got better after a second.
While it wasn’t enough data to win FDA approval, the agency was persuaded to “practice enforcement discretion” — neither an official blessing nor a crackdown. It didn’t apply to companies trying to turn feces into approved C. diff drugs, but it provided the necessary leeway for OpenBiome and those hospitals still making FMTs on their own.
The compromise made some at the agency squirm, worried it would set a slippery precedent. “It’s hard to put the genie back in the bottle,” said one former FDA employee.
They squirmed even more one year later when the founders of OpenBiome started a commercial company called Finch Therapeutics, and competitors cried foul. It was true that OpenBiome charged hospitals only for its materials, as cost recovery, and framed its work as temporary, bridging the gap until a treatment got FDA approval. But the spinoff caused some to view its activities as not entirely altruistic.
“It was almost like business development,” said another former FDA official. “Because to all those customers, you’re going to say, ‘OK, doc, now you can transfer over to our for-profit.’”
Then, in 2019, the recipient of an FMT — not from OpenBiome, but prepared in-house at a hospital as part of a clinical trial — died from a strain of E. coli that wasn’t on the list of bacteria stool preparers were required to test for. Early in 2020, another patient died after an E. coli-containing FMT, this time involving an OpenBiome sample. As far as the stool bank knew, among the 55,000 shipments it had sent out so far, this was the first time a pathogen had been transmitted — but it heightened regulators’ concern. Later that year, Covid-19 arrived, and FMT providers slowed down to make sure that that bug wouldn’t be transmitted, either.
By then, the two new drugs were nearing the market. When they arrived, that provided an opportunity to end enforcement discretion. ”Once you had an approved product — a safe, effective alternative — that made it easy to essentially bring the hammer down,” the second former FDA official said.
First came Rebyota, in 2022, then Vowst the next year. The hammer, when announced, wouldn’t come down across the board. Hospitals could still provide their own FMT in-house. In October 2024, physicians and patient advocates met with the FDA to ask that enforcement discretion for OpenBiome be extended for those patients not covered by the drug approvals. “We basically said, ‘We understand what you’re saying. Just make this carve out,’” said Christian John Lillis, co-founder and CEO of the Peggy Lillis Foundation, a C. diff education and advocacy group. “And honestly, I thought they were going to do it. I thought we persuaded them. I really did.”
But the answer, ultimately, was no.
“I was in shock. I was nearly in tears,” said Stacy Kahn, a gastroenterologist at Boston Children’s Hospital. She got the news while she was caring for a kid with C. diff who hadn’t responded to antibiotics and had landed in the intensive care unit. “I was calling OpenBiome, and I was like, ‘We have a child who is not going to make it if we don’t get these.’” Her team got the stuff; the child survived. But that was the last FMT she performed before OpenBiome stopped shipping. Some doctors thawed out the bags they still had and poured them down the drain.
‘We all feared that Mundo was going to die’
The first time Morales asked Mundo’s gastroenterologist about FMT, the doctor said they weren’t at that stage yet. The team wanted to try more antibiotics to see if that might do what the previous courses hadn’t. Morales needed this doctor; she didn’t want Mundo to be seen as a problem patient. She acquiesced. By September, though, she’d had enough. Mundo had relapsed yet again. Once again, he’d landed in the hospital. There was so much that Mundo had missed. Birthdays. Swims. His first days of second grade. He’d always loved his long hair; he liked to say it was the source of his strength. Now it began to fall out.
“We didn’t sleep during that stay,” Morales said, sobbing. “None of us said it, but we all feared that Mundo was going to die.”
That was when she began pushing for FMT in earnest. Another gastroenterologist had recommended it at this point. “She said, ‘You would have to leave the state to get it done, but our office will try to find you somewhere near home, on the West Coast.’” The place they had in mind was Los Angeles, a four-hour drive away.
Even in previous eras of FMT, the economics weren’t simple. To get a stool donor tested for all sorts of possible pathogens wasn’t cheap, but the doctor couldn’t bill the recipient’s insurance for screening performed on someone else — and the donor’s insurance wouldn’t cover it without a diagnosis. Some people just paid up. Other times, doctors just made up a nonexistent illness.
“They’d say they have diarrhea and do a bunch of stool tests on the person,” said Libby Hohmann, who runs Massachusetts General Hospital’s in-house stool bank. “That’s insurance fraud. I can’t do that.”
During the heyday of OpenBiome, some insurers covered the procedure. Some refused. Some patients would end up paying $2,000 out of pocket, doctors told STAT. Those with C. diff who could show up at the University of Minnesota could — and still can — get FMT for free of charge, care of a nonprofit established by linebacker Peter Westerhaus, whose college football career ended when his ulcerative colitis forced him to have his colon removed.
Now, Morales started making calls. Someone at Mundo’s gastroenterologist’s office gave her the number of a hospital in Los Angeles, but it turned out to be the front desk. They’d never heard of FMT; they transferred her to the organ transplant center. When she found the right number for the right office at the right hospital — Children’s Hospital of Los Angeles — they got an appointment for mid-November. Morales’ husband, a server in a small-bites-and-craft-cocktails restaurant, took yet more time off work.
The day they were to drive was a day of torrential downpours. Rain like it almost never rains in the desert around Las Vegas. The dry lake beds that flanked the highway, usually cracked expanses of tan, were becoming actual lakes. From the backseat, Mundo wondered if they were already in California, somehow, and he was glimpsing the ocean through the storm haze. A drive that should have taken four hours took nearly eight. In another circumstance, Morales might’ve turned around, but this appointment felt existential. She was so nervous that they’d miss it, that something might go wrong, that once they arrived at their Los Angeles Airbnb, they got back in the car and rehearsed the next day’s drive to the hospital.
They got to Mundo’s appointment two hours early. When it was finally time for the long-awaited consultation, Morales was impressed at how well the doctors knew Mundo’s medical file. His six hospitalizations. His six courses of antibiotics. The rash and swelling of hands, feet, face, ears, and neck that occurred with one of the meds. The antihistamines he’d taken to control it. She was impressed at how caring and unrushed they were. But Mundo couldn’t get the procedure he’d come for. As the gastroenterologist wrote in his note afterward: “CHLA is not able to offer FMT given Mundo’s age (must be > 12 to enroll in study).”
In an email, a representative of CHLA said the hospital does provide FMT to children under 12 on a case-by-case basis, and declined to comment on the discrepancy between that policy and the note in Mundo’s file.
The doctor gave Morales two options, Morales recalled. The first was for Mundo to stay on antibiotics from age 7 to 12, and if clinical trials were still running in about four years, he could enroll then. The other option was Vowst, the medication made from some of the bacterial spores found in an FMT.
Four more years of antibiotics made Morales nervous. But she also knew that Vowst was only FDA-approved for adults. She didn’t want to give Mundo a drug that might hurt him. The gastroenterologist assured her she’d prescribed it for other children. The trouble was the money involved. “She mentioned the fact that it’s off-label use for children, and the chances of my insurance approving it were really, really low,” Morales said. But if the request were denied, the doctor went on, she could always try to appeal.
Insurance denials, and then a reversal
The end of “enforcement discretion” changed everything for OpenBiome. “I had to lay off 95% of my staff,” said O’Brien, the CEO. “We are down to two and a half people. We closed our lab, we closed all of our operations.” Instead, it became a foundation, aiming to advance research and provide FMT know-how to other entities. But it also started submitting paperwork to the FDA to start distributing again. That proved complicated, in part because of an intellectual property lawsuit between Finch Therapeutics and Ferring Pharmaceuticals, which sells Rebyota. It took OpenBiome a year to hammer out the bureaucratic details. By the time Mundo was being seen in Los Angeles, in November, OpenBiome was getting ready to submit a research protocol for agency approval.
Mundo’s doctors in Los Angeles had sent in a prescription for Vowst to his pharmacy back home in Las Vegas. Now, Morales started trying to get it covered. She got the first denial on Dec. 9. By the time she called the CHLA team, the doctor there had already filed an appeal on her behalf. Two days later, Morales got another denial. She faxed another appeal on Dec. 30. When she followed up early in January, the company said it hadn’t received it. She drove to its offices to deliver a paper copy in person.
She was on the highway when the insurer called a few days later, driving to the mechanic. “They said, ‘We would like to let you know that we received your appeal, but the trustees have told us that you’ve already appealed this, and they denied you a couple of times. They had an outside gastroenterologist look at this, and they decided that your medication is not medically necessary,’” Morales recalled.
It was Jan. 9. Mundo had been sick since April. “I was defeated. I had nothing in me left. I just broke down,” she said. “I wanted to throw up.” She had to remind herself to focus on the road.
She and her husband began talking about other possibilities. They could try doing a DIY FMT at home, but she was too worried that they might hurt Mundo. They could sell or refinance their house, to pay the $19,000 for Vowst themselves. They could fly to Minneapolis, which felt risky: Immigration and Customs Enforcement had descended on the city, apprehending people no matter their immigration status, and as far as Morales could tell, many of the people being targeted looked and sounded like her family. “We are Hispanic, and our names are very Hispanic,” she said.
Then, all of a sudden, a few days later, the same insurance representative with whom she’d been sobbing on the phone from the highway called back. “I want to let you know I went into my system, and I was going to send your denial letter for medication, and I noticed that it said ‘pending,’” Morales remembered her saying. “I don’t know if this is good or bad, but I’m letting you know.” A few days after that, on Jan. 15, Mundo’s Vowst prescription was approved.
The pills arrived in early February: 12 of them. He was to take four each day for three days. These were even bigger than the ones Mundo had to learn to swallow to avoid IV antibiotics. It was a struggle. In a video Morales filmed, you can hear her whooping when he gets the first one down — a wild, visceral sound of being one step closer to done with this ordeal.
“See, you can do it!”
“That didn’t even feel like nothing,” Mundo says. He holds up the second pill. “I can do this one, second try. Maybe first.”
But then he gags. He tries again, this time getting so far as taking a sip of water — then freezes up and spits it out.
“Put it on the napkin,” Morales instructs. “Dry it, dry it, dry it.” She didn’t want any of these hard-won pills to dissolve before Mundo could reap any benefit. Individually, each one cost $1,640, but to her, they were much more precious than that.
It took Mundo 25 minutes to take his first four capsules. He only had two more days of this to go. When he finished the course, he stayed better. Morales continued looking in the toilet before he flushed, to make sure there wasn’t trouble brewing. “I’m so happy to report they’re the most perfect and beautiful poops I have ever laid eyes on,” she said. “They’re just textbook poop, like the emoji.”
In some ways, this was a success. Mundo’s illness had dissipated after he had received an FDA-approved drug, which was covered by insurance. But the time and effort involved is more than some patients have. Morales is a full-time mom, and it was nearly too much for her. In the case of a patient with severe C. diff who is in the ICU, taking pills may not be an option, and waiting weeks or months for treatment may be too long.
The old version of enforcement discretion is unlikely to return for FMT, though there’s been an administration change and many of the officials involved in closing that loophole in 2024 are no longer at the agency. “FDA recognizes that microbiome-based products are being studied for a variety of diseases, conditions and populations. We continue to work with companies to advance the development of their products. Existing regulatory pathways are applicable,” a spokesperson wrote in an email to STAT.
The agency responded to the OpenBiome Foundation’s protocol by the deadline of March 13 — but only to say that it needed more time to evaluate, and it didn’t indicate when a decision would arrive. Morales hopes it isn’t necessary — but if Mundo’s C. diff does come back, she’ll take him to the University of Minnesota.
This story has been updated with a comment from the Peggy Lillis Foundation CEO.
