Frequently Asked Questions

 

What is FMT?

FMT stands for Fecal Microbiota Transplant. It’s a microbial therapy that delivers stool from a healthy person into the colon of a sick person. This procedure creates a healthy balance of bacteria within the sick person’s colon, allowing for them to get better.

For more detailed information, check out our What is FMT page.

What is C. diff?

C. diff, or Clostridioides difficile, is an opportunistic infectious bacteria that causes severe diarrhea. Other symptoms include abdominal pain, discomfort and/or fever. This infection can result in dehydration, toxic megacolon, septicemia, and death. Current treatment requires antibiotic therapy, but antibiotic-resistant strains of C. diff are on the rise.

For more detailed information, check out our page about C. diff.

How do I know if I have C. diff?

Symptoms of C. diff include 3-30 severely watery stools a day, as well as abdominal pain and/or fever.

You need to have a physician run an EIA (also called ELISA or Immunoassay) to diagnose that you have a C. diff infection producing toxins A and/or B.

A stool test shows I have C. diff. Do I qualify for FMT?

Maybe. Up to 5% of people have C. diff in their gut, but are unaffected. The percentage is even higher in healthcare workers and people who have recently been hospitalized.

A healthy gut will keep C. diff under control, and it will not overgrow or produce toxins.

However, when there is a shift in the gut microbiome, due to antibiotics, or other health issues, the low level of C. diff can start to grow out of control, and start producing toxins A and/or B.

Active toxin production is the hallmark of an active C. diff infection.

This is why EIA toxin testing is required.

What kind of C. diff testing counts?

PCR test: no

NAAT test: no

GI MAP test: no (we understand this is one is especially confusing because it can show a positive result for the presence of C. diff that has the potential to produce toxin A or B. An EIA test is the only way to see that the toxins are actively being produced.)

EIA (aka ELISA or Immunoassay) toxin test: yes!

Why do you require an EIA test? Why isn’t PCR enough?

Up to 5% of people have C. diff in their gut, but they are unaffected by it. The percentage is even higher in healthcare workers and people who have recently been hospitalized. They are “colonized” with C. diff, meaning the “colonization,” or presence of the bacteria, will show up on a PCR test. But again, they are usually unaffected.

Sometimes, these people will have diarrhea. However, the diarrhea is not necessarily caused by C. diff toxins. If it is caused by C. diff toxins, an EIA test will be positive. If it is negative, it is important to get to the root cause of their diarrhea (not C. diff toxins) and treat it appropriately (not with FMT).

How safe is FMT?

FMT is an incredibly safe therapy. The short-term safety studies have reported extremely low rates of serious adverse events. Most adverse events that have been reported are minor, for example bloating, diarrhea and nausea. There have been a few studies that have followed patients over 3 years and those also show good safety outcomes, in fact they show better outcomes compared to patients who were effectively treated with antibiotics. The biggest risk with FMT is potential infection. This risk is largely mitigated through extensive donor screening, but like many things, we don't know what we don't know.

Interested in learning more about our safe practices for FMT? Check out our Quality and Safety page.

How effective is FMT?

According to recent studies, oral FMT capsules have been shown to be just as effective as colonoscopic delivery, with a cure rate of 96.2% in treating C. diff. And, when compared to treatment with Vancomycin, FMT is more effective.

How do I know if FMT is right for me?

If you have C. diff and you've failed at least one round of antibiotic treatment, then FMT may be right for you.

Current guidelines from the AMA and IDSA strongly recommend the use of FMT after the second recurrence of C. diff. So, if you've been treated, but still haven't found resolution of symptoms, come talk with us. FMT is a safe, effective option to address recurrent/antibiotic-resistant C. diff infections.

If you are feeling uncertain about FMT and have more questions, feel free to Contact Us and we’ll be happy to discuss your concerns.

What are the different kinds of FMT?

There are several methods of FMT treatment, these include:

  1. Oral capsules

  2. Colonoscopy

  3. Retention enema

  4. Upper-gastric tube

What kinds of FMT do you offer?

We no longer offer frozen oral FMT capsules (since October 2023).

Can I try FMT if I don’t have recurrent C. diff?

Unfortunately, we cannot treat any patients that do not have C. diff infections that have not responded to standard therapies. And we no longer make frozen oral FMT capsules as of October 2023.

If you are interested in the research and resources about clinical trials for FMT for other diseases, we are happy to talk to you, and do our best to point you in the right direction. We are also happy to provide other fecal-derived microbial therapies.

What are the FDA requirements for FMT treatment?

Currently, under the FDA Guidelines, we are allowed to use FMT to treat patients with C. diff not responding to standard therapies. Two pharmaceutical options are now available: Rebyota and Vowst.

To learn more, check out our FDA Guidelines page.

I don’t want to take antibiotics. Can I start with FMT to treat my C. diff?

Unfortunately, no. Due to current FDA guidelines, we are only able to provide FMT treatment to patients with antibiotic-resistant or recurrent C. diff. For more information, check out our FDA Guidelines page.

Where does the FMT for your capsules come from?

As of October 2023, Flora Medicine no longer manufactures frozen oral FMT capsules.

What to look for in donor screening?

Donors should not have any significant health issues, are not on any pharmaceutical medications, and have a history that supports a healthy microbiome. For example, our donors were all born vaginally and breastfed with less than five rounds of antibiotics in their life and none in the past several years. They ate whole foods, organic diets high in fiber and plant diversity with little to no processed foods. And most importantly, they were happy healthy humans.

Extensive blood and stool screening for any infectious diseases that might be transferred through the stool to the recipient should also be conducted on a semi-consistent basis.

How much does your FMT cost?

We no longer supply FMT.

For every patient being treated by Flora Medicine physicians, we require an initial $450 office visit.

Is your FMT covered by insurance?

No. We have not seen oral capsules for FMT covered by insurance. However, you are free to try. Rebyota claims insurance reimbursement for their product, Vowst is still unknown.

How long does FMT treatment take?

The standard C. diff dosing regimen lasts between 1 and 4 days, however, your provider will give you dosing instructions specific for you, based on your medical history.

How long does it take for FMT to work?

We generally see improvement in symptoms within 24 hours. Often patients will experience their first formed stool within this time period. For patients that have had severe disease over a long period of time, it may take longer for a formed stool. In either scenarios, C. diff is still cleared quickly and can be demonstrated with negative toxin testing.

Can another physician, like my own doctor, treat me with your FMT?

As of October 2023, Flora Medicine no longer manufactures frozen-oral FMT capsules.

How do I prepare for FMT treatment?

In order to prepare for FMT treatment, we ask patients to avoid the use of antibiotics and proton-pump inhibitors (PPIs) at least 24 hours before your first dose. Ideally, we would have you take the capsules on an empty stomach and allow at least a couple of hours before your next meal.

How likely is it that my C. diff will return after FMT?

Recurrence is dependent on various factors, what your exposures may be (antibiotic use, spores remaining from your first infection, hospitalization, etc), your age, and your living situation.

That being said, FMT is more than 90% effective at treating and curing C. diff infection, that number increases to 96.2% if the person receiving treatment has to undergo two FMT treatments. Many of the studies follow participants, or those who have received FMT for their C. diff infection, for 8 weeks, sometimes even longer. And in these studies, researchers are finding that individuals treated with FMT sustain cure. 

Can I be on antibiotics during FMT treatment?

We recommend stopping your antibiotic 24-48 hours before you ingest an FMT product. This is done in order to protect the healthy microbial diversity delivered in the FMT to the recipient which is how it cures C. diff for good.

How will FMT treatment affect my diet?

After receiving FMT, we ask you don't eat one hour after treatment. Aside from that, you can continue to eat your normal diet, with a few caveats.

Many of the foods available in fast food restaurants or even at your local market contain antibiotics. Avoiding these foods is essentially to maintaining the newly transplanted microbiome you've just spent previous time and money on. We recommend a whole foods based diet not only to support your body, but the microbes we just introduced into your system, they like to eat too! If you need guidance concerning nutrition, we are happy to help.

I don’t live in Oregon or Washington. Can you treat me with FMT?

Flora Medicine since October 2023 is no longer provider frozen oral FMT capsules.

I have more questions about FMT.

Our front desk staff are more than happy to speak with you further about FMT basics. You can contact us here.

Questions that go beyond the scope of this FAQ or our front desk staff (who are not trained medical professionals) can best be answered with a 30 minute educational consult with one of our physicians. You can schedule here.

You can also check out these helpful links:

OpenBiome: https://www.openbiome.org/about-fmt

New Documentary about FMT: https://designershitdocumentary.com/

Peggy Lillis Foundation: https://peggyfoundation.org/

Mark Davis Ted Talk: https://youtu.be/C9bYKd_Ffgc 

NPR Article: https://www.npr.org/sections/health-shots/2013/09/10/216553408/microbe-transplants-treat-some-diseases-that-drugs-cant-fix