Well, this seems like seriously big news in the microbiome world: Fecal Tx Flunks IBD Test but Optimism High. Charles Bankhead reports on results presented at the “Digestive Disease Week” meeting. At the meeting Paul Moayyedi from McMaster University reported that a clinical trial of fecal microbial transplants (FMT for short) was stopped midway through the trial due to “lack of efficacy”. More specifically Bankhead reports
The investigators found no significant differences in the primary outcome or any of the secondary outcomes, which included the Inflammatory Bowel Disease Questionnaire and the EQ5D health status assessment
The researcher seems enthusiastic about FMT still but certainly this means that FMT for IBD is not going to be like FMT for CDiff (just wanted to make sure I got in a lot of abbreviations there). I am sure there will be much more to come on FMT and it would be good to see more detail on what was presented at the meeting (a paper, or poster, or such). But for now, this hopefully will temper some of the overselling of FMT that is going around (e.g., Overselling the microbiome award: Mercola/Perlmutter on fecal transplants for severe neurological dysfunction).
Well, this is pretty scary.
An automated Google Search I have picked up a hit to an article by Mercola about an interview he did with David Perlmutter: Key Dietary Strategies to Protect Yourself from Alzheimer’s : Natural Wellness Review
And the article covers many topics but one is pretty over the top. There is a section on recommendations by Dr. Perlmutter to promote brain health. And one of them is quoted below:
Fecal transplantation, in cases of severe neurological dysfunction where poor gut flora appears to be a contributing factor. Your microbiome is critical for multiple reasons, including regulating the set point of inflammation, producing neurotransmitters like serotonin, and modulating systems associated with brain function and brain health. This form of therapy is now the standard of care for life-threatening C. difficile infections.
Yup. He is recommending fecla transplants to treat severe neurological dysfunction. Not the first person to suggest a connection between microbes and neurology. Not the first person to say that maybe trying to change the microbiome might be an interesting thing to test as a treatment for some issues. But with no caveats here they just jump right in to using this to treat neurological dysfunction. This is just grossly over the top and will likely mislead many many people with neurological dysfunctions into thinking fecal transplants are a known effective treatment. I wonder if Dr. Perlmutter will start offerring home fecal transplant kits for sale on his web site (which I will not link to here).
Now, I think microbes are important. And I think there is potential here for fecal transplants for a lot of issues. But potential is different than proven. By a long show. And people like Mercola and Dr. Perlmutter should be ashamed for misleading people like this. And thus they are today’s winners of an “Overselling the Microbiome” award.
Wow – fascinating story by David Glenn in the Chronicle of Higher Education: Student-Led Project Banks on Promise of Fecal Transplants – Research – The Chronicle of Higher Education. The article tracks the story of Carolyn Edelstein and Mark B. Smith and James Burgess who have created a feces bank called OpenBiome to provide materials for fecal transplants.
Some related posts of mine:
I love things like this. A simple Youtube video from Antonio González Peña and Rob Knight’s group. The video shows data from a study of microbial communities and how they respond to a fecal transplant. Simple. Short. And the visualization is nice.
Well, if you are between 18 and 70 and are healthy and want to participate in a clinical trial this may be for you. Titled Autologous Fecal Therapy the description uses some science jargon to describe the plan. They say
“Ten healthy volunteers will be recruited to receive either an autologous stool transplant or a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly, and safely, restore a patient’s fecal microbiome after antimicrobial exposure.”
Or, in other words – they want you to (1) save your shit (2) take some antibiotics and (3) deliver either salt water or your own shit back into your rear.
Actually quite interesting. And I encourage people to consider volunteering. But I just thought it would be good to make sure you knew what this was about …
Just read this: Gut Bacteria Transplant: A New Treatment For Anxiety? | Psychology Today: calm vs. anxious. On the one hand, I agree that the microbiome very well may have interesting effects on human behavior. Well, actually, we know the microbiome does impact human emotion and behavior. For example, I get pretty anxious when I have gut problems, and we certainly know that the microbiome has a major impact on gut health. And of course, we know lots of examples of microbes affecting behavior of animals. The latest on this that I am aware of comes from studies by Wendy Ingram in my brother’s lab at UC Berkeley – who has been looking at Toxoplasma and it’s effect on mouse behavior (e.g., see Toxoplasma infection permanently shifts balance in cat-and-mouse … and Cats, Mice and Toxoplasma Gondii Parasite Weird Love Triangle and Mice Aren’t Scaredy-Cats When Infected By Toxoplasma).
On the other hand, despite the apparent connections between microbes and emotion and behavior in some cases, this does not mean either that (1) microbes have a role in causing anxiety in people or (2) even if microbes CAUSE anxiety that microbiome transplants could treat the anxiety. Anyway – I certainly think this is an interesting area of research but I urge caution before we go overboard in marketing fecal transplants for everyone with any issues connected to behavior or emotions …
Some interesting tidbits in this Jerusalem Post article: Health Scan: Ungluing the complexity of allergy | JPost | Israel News (a bit overenthusiastic too but just thought I would point some of these lines /quotes out):
- “Studies in adults show that more than 90 percent of patients are cured following such therapy and, experts say, they have every reason to believe the numbers would be equally impressive in children.” – not sure this is true (i.e., the 90% cured level).
- In less than a decade, we’ll have lab-cooked poop that we can administer to restore balance in the guts of people with a wide array of conditions caused by the imbalance between good and bad germs.” OK – a bit overenthusiastic
- But this is my favorite: “The concept is hardly new. The method originated with ancient Chinese healers who gave their diarrhea-ravaged patients “yellow soup,” a concoction of fecal matter and water. Thousands of years later, the delivery approach has evolved” – So – I have been writing and talking about fecal transplants for a while now (e.g., see this) and have linked them to coprophagy and poo tea and such but never heard of the yellow soup thing.
I guess today is fecal transplant day. So why not a little news story from Health2Fit about families that share everything …
Interesting discussion of Fecal Transplants is this letter from the American Hospital Association to HHS about Medicaid / Medicare: Marilyn Tavenner September 6, 2013 Page 1 of 33 September 6 …
Key text is below:
“FECAL MICROBIOTA TRANSPLANTATION
Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy, or human probiotic infusion, is a medical treatment for patients with Clostridium difficile (C. difficile) enteritis or ulcerative colitis. C. difficile infection occurs in patients who have been administered antibiotics for a long period of time. The antibiotics destroy important disease-fighting bacterial flora in the intestine. Fecal transplants are believed to restore the bacteria back to normal, and the patient can recover. The fecal transplant works by repopulating friendly flora in the infected intestines. The donated feces is screened for disease and then mixed with a saline solution to the consistency of a “milkshake.” FMT can be performed by various routes including nasogastric (NG) tube, nasojejunal tube, upper tract endoscopy (EGD), colonoscopically or by retention enema. However, based on an editorial published in the Journal of Clinical Gastroenterology (Volume 45, Number 8, September 2011), colonoscopic FMT is the preferred method for the vast majority of C. difficile infection patients, and if carried out early, may prevent development of severe infection.
Effective with the 2013 edition of the CPT manual, the American Medical Association developed the CPT code 44705 (Preparation of fecal microbiota for instillation, including assessment of donor specimen) that includes:
- development of the intestinal instillate for the recipient; and
- evaluation of the donor specimen, including the physician review of results of testing the donor’s specimen for infectious pathogens
The CPT manual instructions require that the actual instillation or fecal microbiota transplant be coded separately using CPT 44799 for either oro-nasogastric tube or enema. Additional instruction in the CPT manual identifies that all laboratory testing provided for the patient is to be reported separately. Based on this instruction and the intent of the CPT code 44705, this is an add-on or “list separately in addition to the primary procedure,” which would be the instillation procedure, e.g., the oro-nasogastric tube or enema.
By contrast, effective Jan. 1, 2013, CMS created HCPCS code G0455, Preparation with instillation of fecal microbiota by any method, including assessment of donor recipient, and assigned it to APC 00340, with a payment of $49.64. The payment for code G0455 appears only to cover the work related to the preparation of the donor fecal microbiota specimen, which may also include the review of the donor lab results for presence of pathogenic microbes. However, the payment does not appear to recognize the work to prepare the patient for the implantation or the instillation of the donor microbes, or the work performed and supplies consumed during the instillation procedure. The additional cost to perform this portion of the procedure would include the supplies, e.g., nasogastric tubes (approximately $5 each), enema tubes (approximately $25 each), other disposables including drapes, gloves, gowns (approximate cost of $20); the overhead expenses are not considered in these additional costs. In addition, if the microbiota instillation is performed via colonoscopy or EGD, the payment does not recognize the cost of the endoscopic procedure. This is demonstrated by the CPT codes and corresponding APC payments as follows:
- Using EGD as method of instillation: Loss of APC 0141 for EGD with code 43200, Esophagoscopy, rigid or flexible; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure), with a payment of $623.45 (minus Significant Procedure, Multiple Reduction, if performed with other procedures).
- Using colonoscopy as method of instillation: Loss of APC 0143 for colonoscopy with code 45378, Colonoscopy, flexible, proximal to splenic flexure; diagnostic, with or without collection of specimens) by brushing or washing, with or without colon decompression (separate procedure), with a payment of $691.32 (minus Significant Procedure, Multiple Reduction, if performed with other procedures).
We recommend that CMS delete code G0455 and replace it with three new G codes:
- Create a new G code for “Preparation of fecal microbiota with instillation by oro- nasogastric tube or enema, including assessment of donor recipient,” and place it in a more appropriate APC to include the costs of the supplies. We prefer that a new code be created (rather than revise existing code G4055) since the meaning of the code would be significantly different and would confuse any future data analysis if the same code would include different methods of instillation.
- Create a second new G code for “Preparation of fecal microbiota with instillation by upper endoscopy, including assessment of donor recipient,” and place it in APC 0143, Level I Upper GI Procedures.
- Create a third new G code for “Preparation of fecal microbiota with instillation by colonoscopy, including assessment of donor recipient,” and place it in APC 0141, Lower GI Endoscopy. “
See this Craigslist post for the Boston area: Are you a healthy adult, 18-50 years old? – copied below. It seems that fecal transplants really are everywhere …
Are you a healthy adult, 18-50 years old? (Massachusetts General Hospital)
Fecal Microbiota Transplant
Healthy adult volunteers 18-50 years old
Involves donation of stool samples and medical screening
Blood draws, complete medical exam
No medical problems
5-7 out-patient visits at MGH
Compensation up to $700 for completion of study
Posting ID: 4050676649
Posted: 2013-09-06, 4:04PM EDT
Updated: 2013-09-06, 5:09PM EDT