June 2, 2023
It’s early 2008, a few weeks after New Year’s celebrations.
Lara Thompson, a researcher for HIV prevention living in Rhode Island, is enjoying her day when unexpectedly, she begins to feel nauseous; soon after, diarrhea hits. Thinking her symptoms were due to her overindulgence during the holiday celebrations, she expected them to pass within a few days – they didn’t.
In fact, in the following weeks, Lara's life completely fell apart.
She dropped roughly 20 pounds, was too lethargic to participate in her daily activities, and had to be within running distance of a bathroom at all times. Her work put her on a leave of absence in fear she might pass her symptoms to the patients she was closely working with.
Not getting any better, Lara sought medical consultation.
Soon after, she discovered that her intestinal lining had become infected with Clostridium difficile (C. diff), a miserable disease that occurs when an individual's gut bacterial equilibrium is disrupted due to antibiotic exposure.
Although C. diff is more common in people over 65 years old, it can affect anyone. Symptoms include:
Lara felt them all.
After her diagnosis, she was promptly put on a drug treatment plan – her infection loved it. The medication did not alleviate her symptoms; in fact, they persisted and worsened. For months, the doctors kept trying different drug regimes, and all the while, Lara’s health kept deteriorating: she was down 40 pounds, her hair began to fall out, and her muscles slowly depleted.
Desperate for a solution, Lara began to scour the internet when she came across a lesser-heard-of, alternative treatment promising a drug-free resolution to her problems – a fecal transplant.
Fecal transplantation is a profoundly simple, cutting-edge treatment that takes the stool of a healthy patient and introduces it into a patient’s gastrointestinal tract – curing those with hard-to-treat intestinal infections with remarkable speed.
Devastated by her current condition, Lara sought a doctor willing to undertake the procedure.
"It made sense to me," Thompson says now. "And I had no other options. I was getting sicker, basically living in the bathroom
crying, emotional all the time."
Using her boyfriend as her donor, Lara undertook the procedure. Within two hours, her condition improved, and after three years, it never came back.
Lara’s recovery was nothing short of miraculous, and it was all thanks to the power of feces. Yet, for a procedure that is low-cost, minimally invasive, and helps cure 90% of patients, little is heard of it, and regulations are significantly lagging behind.
Why is that?
Fecal transplants pose a challenge for the Food and Drug Administration (FDA). In 2013, they started to regulate the treatment as an experimental drug. This meant that doctors could only perform transplants under FDA-approved clinical trials. This would be a tremendous undertaking as the amount of paperwork required: detailed information on the drug, the study design, and the safeguards for patient protection would take months or even years to file and get approval.
This led to many patients seeking DIY methods found via forums, videos and blogs.
In fairness, the FDA’s concerns are warranted. Improperly screened feces can lead to patients contracting HIV, hepatitis and other viruses/parasites from fecal matter. Additionally, little research has been done on the long-term side effects of stool transplantation.
However, when 15,000 people die of C. diff each year in America – the urgency to find a cure today outweighs the potential long-term side effects of tomorrow.
Luckily, in 2022 a major milestone was reached when the FDA approved the first fecal microbiota therapy for recurrent Clostridioides difficile infection (CDI), alongside regulatory requirements for stool banks providing fecal microbiota transplantation (FMT) products.
Ferring Pharmaceutical has become the first company to have a fecal transplant/microbiota-based therapy product approved by the FDA. The product, named Rebyota, is prepared from stool tested for a panel of transmissible pathogens donated by qualified individuals. It’s an enema product administered rectally as a single dose.
While most patients and doctors were eager for the approval of a pill, this is still an exciting development.
Healthcare professionals who wish to use fecal transplants to treat patients with C. difficile now have the option of using stool from known donors or Rebyota. Considering the ease of access to Rebyota, it likely will become a popular treatment option.
Yet, there is still work to be done.
While the approval of Rebyota provides great access for C. diff patients, it is not a first-option treatment, meaning patients are still required to undergo a series of drug treatments before attempting Rebyota or fecal transplantation. Additionally, it does not help patients with other conditions who are interested in trying fecal transplants today.
There is much excitement and impressive research available for fecal transplant’s ability to treat conditions such as Crohn’s, Colitis, Autism, Parkinson’s, and more. However, fecal transplant for these conditions is still experimental and only approved through clinical trials. Hopefully, access to this product will make clinical trials easier to set up and lead to greater amounts of clinical trials for other conditions.
Patients who are interested in trying fecal transplants can use ClinicalTrials.gov to search for trials available near them.
Fecal transplant is a promising medical breakthrough that can treat various conditions that have proven difficult to manage with traditional interventions. While access to fecal transplants for conditions other than C. diff is still limited, recent developments, such as the approval of Rebyota, provide hope for the future of fecal transplants. Clinical trials remain the only legal pathway for patients to access fecal transplants. While the process can be challenging, it is a promising option for patients with chronic illnesses like Crohn's, Colitis, and IBS.
If you’re interested in learning more about fecal transplants and the microbiome, including interviews with leading researchers and first-hand accounts from patients who have successfully undergone a fecal transplant, check out our documentary film "Designer Shit."