A procedure some might consider unconventional has proven to be an effective treatment for a serious and chronic type of bowel disorder.
Fecal Microbiotal Transplantation, or FMT, calls for the transplantation of healthy fecal material into the colon of a person infected with Clostridium difficile, also called C. difficile or CDI. The procedure restores compromised stool and stops the recurrence of CDI.
According to the Centers for Disease Control and Prevention, C. difficile affects 250,000 Americans each year. About 20,000 patients died from it yearly from 1999 to 2004. The bug is associated with health care settings and with the use of antibiotics.
CDI is caused by the use of certain antibiotics that alter the microbial material in a person’s gut. Many patients who contract C. difficile will not have symptoms or will fight it successfully with antibiotics. In patients who have compromised stools, CDI can cause recurring and life threatening diarrhea and inflammation of the colon.
In people who are infected with CDI, a first recurrence happens 15 to 20 percent of the time. Of those people, 30 to 40 percent will have another recurrence. Of those, another 50 percent will have a recurrence. All told, fewer than 5 percent will experience a chronic cycle. The traditional treatment to date has been taking tapering doses of the antibiotics vancomycin or rifaximin. For many people with recurring CDI, these treatments have largely not been successful.
CDI cases were rare before the 1990s but have become a lot more widespread. The first randomized control trial for FMT happened in 2013. The trial included 42 patients and had to be stopped because patients treated with FMT had a cure rate in the order of 90 percent or above. Patients who were on medication were having a 20 to 30 percent success rate. Because of the disparity in success rates, it was thought to be unethical to not offer FMT to all patients suffering from CDI.
At Michigan Medicine, the FMT process is started by referral to the Infectious Diseases clinic, which can be done by the patient themselves or their physician. FMT at U-M is offered after two occurrences and failed treatment with metronidazole or vancomycin or fidaxomicin. Although patients can still find their own donor for the stool, this is discouraged as stool banks have been safe and effective and are now the preferred route. U-M partners with OpenBiome, a non-profit organization, to obtain the stool. Openbiome is currently used by over 650 health care institutions.Preparing for FMT is similar to preparing for a colonoscopy. Recipients on antibiotics must stop taking them 48 hours before the procedure to ensure the antibiotic does not kill the bacteria in the stool. We also ask that they take the anti-diarrhea medication Imodium a few hours before the procedure. The recipient is infused with the stool while under anesthesia. After they are infused, patients are placed in a position that allows them keep the transplanted stool in the colon as long as possible. In the case of FMT by fecal capsules, the preparation is more involved, individually tailored, and requires coordination with the consulting physician. The fecal capsules are administered in the ID clinic.
Who pays for the procedure?
The cost of a colonoscopy and/or office visits are generally covered by insurance. Unfortunately, the OpenBiome stool product is expensive, not FDA approved, and not covered by insurance, but we work with patients to find affordable options when possible. We are not making a profit, but need to be reimbursed for the cost of the material and in some cases state regulations do not allow us to collect the payment after the procedure is done. Further details will be provided by your provider ordering this procedure. In the case where a patient selects their own donor, there may still be a risk of increased cost since we screen donors for transmissible infection (see below) and the donor’s insurance may charge for that.
How are donors selected?
The OpenBiome donor selection criteria are rigorous and exhaustive. A full description is available on their website.
For patients where OpenBiome is not an option or they prefer to find their own donor, our institution has its own criteria. A donor must be relatively healthy with no chronic medical conditions and have normal, well-formed bowel movements, two to three times a day to every three days. We want them to have not used antibiotics in last six months. If a donor has used antibiotics, their stool may not be so healthy. The donor must also pass screening tests to ensure we are not passing along disease. For example, we test for HIV and we make sure the donor does not have CDI. Sometimes people will carry CDI but not have symptoms.
For the stool preparation itself, the donor must collect stool the morning of procedure. Then they mix it with saline and blend it at home using a previously purchased single-use blender to milk shake consistency. The donor must then store it in a Ziplock bag and bring it to the hospital.
After the procedure, the patient can go home and in majority of cases start having healthy, normal bowel movements after 24 to 48 hours. For first 24-48 hours they will have a little bit of bloating, mild cramping, abdominal pain but it rarely persists.
How do people feel about this procedure?
At first it was thought people would not be open to it but CDI has a drastically negative effect on the quality of life of people who suffer from it. Most people are willing to try anything to get their life back.
We started doing FMTs in June 2012. We have performed hundreds, almost all of which have been successful. FMT will not make you immune to CDI. Using antibiotics again puts a person at risk for a recurrence.
There are many classes of antibiotics that are associated with CDI, which are used for a whole host of conditions. Antibiotics are amazing drugs. They’ve saved many lives. But they’re a double-edged sword. CDI is one complication of many. Following FMT many patients maintain a relationship with their infectious diseases provider for guidance on future antibiotic needs that can minimize risk of another CDI episode.
Are there any known risks to FMT?
More research is being done on microbiota in the stool to determine links to obesity, hypertension, autism, cancer and diabetes. We believe there are features in microbiota that predispose people to these conditions. We don’t know what the long-term consequences are. We are hoping to do a lot more research so we can understand long-term effects of FMT.