Fecal matter transplant
A fecal matter transplant or fecal microbiota transplant (FMT) is a therapy that involves the transfer of fecal waste from a healthy donor to the colon of a patient. At present, in the U.S., fecal matter transplant is regulated by the FDA and is only approved for use in severe or reoccurring clostridium difficile (c.diff) infections. In the UK, some clinics, such as the Taymount Clinic offer FMT for a wide range of GI and chronic illnesses.
The U.S. Food and Drug Administration (FDA) has classified human stool as a biological agent and determined that its use in fecal matter transplantation (FMT) therapy and other research should be regulated to ensure patient safety. In order for a physician or researcher to use FMT in a clinical trial or to treat any condition other than reoccurring, antibiotic-resistant clostridium difficile infections, an investigational new drug (IND) permit is required.
The FDA regulation hasn't stopped people with other illnesses, especially GI illnesses, such as ulcerative colitis or irritable bowel syndrome, from experimenting on their own with FMT. Recipes for do-it-yourself FMT are abundant online, including Dr. Sarah Myhill's protocol, Probiotic Therapy Home Infusion Protocol.
Fecal matter from a person with healthy gut flora is mixed with saline, strained, inserted into the patient with Clostridium difficile colitis via a colonoscopy, endoscopy, sigmoidoscopy, or enema in order to recolonize the ill person's bowels. It is recommended that the donor be someone close to the patient, with the first choice being a spouse or significant other, but other close friends, relatives, or a “universal donor” source may be warranted. The physician should ensure that the “universal donor” source employs rigorous screening and testing standards. Testing includes screening the donors’ blood for diseases like HIV and hepatitis and testing their stool for bacterial pathogens, giardia and cryptosporidium, parasites, and C. difficile.
Chronic fatigue syndrome
A 2012 study using a variety of antibiotics followed by 1-3 fecal matter transplants (and in six patients an oral course of cultured bacteria), reported a 70% rate of improvement of sleep and "lethargy/fatigue" symptoms in Fukuda CFS patients recruited from a clinic for digestive disorders. The authors reported a 58% success rate at long term followup 15-20 years post-treatment, but only 12 patients (out of the original 60) were contacted at that point. Accordingly, the long-term followup results would not have been statistically significant.
That study also neglected to use any objective outcome measurements, a control group was not included, and the symptoms used to determine a successful outcome regarding "CFS symptoms" did not account for physical limitations or many other fundamental ME/CFS symptoms. It is not clear how many symptoms were measured before and after treatment, hence it cannot be determined if any results were statistically significant. Furthermore, all patients were recruited from a clinic for digestive disorders, which would suggest that they were not typical ME/CFS patients. The recruitment criteria did not require that patients have the symptom of post-exertional malaise, hence the results may not be applicable to ME/CFS patients meeting more stringent criteria.
There was no study protocol published, and there is no explanation provided for the results first being published as a full paper fifteen years after the initial treatments took place. A conference poster abstract from 1995 indicates that other symptoms were tested at an earlier followup, but those symptoms are not reported or discussed in the 2012 long-term followup, which may indicate that the treatment was less successful than reported. The poster abstract does not appear to have been published, and the full long-term followup was published in an obscure online journal with no apparent peer review process.
This study has not been replicated, and no other studies for FMT and ME/CFS have been conducted. Accordingly, the existing evidence base in favor of this therapy is very weak.
- The Fecal Transplant Foundation
- Dr. Sarah Myhill's Home Infusion Protocol
- Infectious Diseases Society of America Information about FDA regulations re: FMT
- The GI Microbiome and its role in Chronic Fatigue Syndrome: a Summary of Bacteriotherapy, Journal of the Australasian College of Nutritional and Environmental Medicine, Vol. 31, No. 3, Dec 2012: 3-8.
- Bacteriotherapy for chronic fatigue syndrome a long term follow-up study