Fecal Microbiota Transplant Treatment Approved by the FDA

The balance of microbial populations making up the gut microbiome changes with age in ways that produce harm, such as loss of beneficial metabolites, and generation of chronic inflammation. This form of aging is only loosely connected to age-related damage in our tissues, in that animal studies appear to show that a readjustment of the balance of populations in the gut microbiome of an aged animal, making it more youthful, will persist even as aging progresses in the body. In killifish, the result is improved health and extended life span; in mice, similar studies have demonstrated improved health, with lifespan studies yet to take place.

One of the approaches capable of rejuvenating the gut microbiome is fecal microbiota transplantation, a procedure that is exactly as it sounds. As a matter of interest to the longevity community, one implementation of fecal microbiota transplant is now FDA approved for treatment of C. difficile infection. This approval will make it a great deal easier for groups with the motivation and funding to run low-cost clinical trials to demonstrate that fecal microbiota transplantation from young to old individuals will improve function and health in the older recipient. I believe that this sort of activity, aimed at convincing physicians and the public that rejuvenation is possible, is important and necessary to accelerate progress towards greater human longevity. Once a treatment is approved for one use, it can in principle be prescribed off-label by any physician. This specific packaging of the fecal microbiota transplant procedure as a medical product is not assembled with young to old transplants in mind, but as is the case for albumin harvested from donated blood, donors tend to be on the younger side.

This FDA approval probably doesn't make a great deal of difference to self-experimenters interested in fecal microbiota transplantation as a way to potentially beneficially adjust an aging gut microbiome. It was already possible to use services, such as Human Microbes, to purchase screened stool samples in order to conduct the treatment oneself. There is a thriving market in this sort of service, forums to connect people, and a plethora of quiet, individual efforts to improve various common forms of gut dysbiosis outside the medical system. Aging is its own form of gut dysbiosis, so why not that as well?

FDA Approves First Fecal Microbiota Product

Today, the U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI. Clostridioides difficile (C. difficile) is a bacterium that can cause CDI, a potentially life-threatening disease resulting in diarrhea and significant inflammation of the colon. In the United States, CDI is associated with 15,000-30,000 deaths annually.

The intestinal tract contains millions of microorganisms, often referred to as the "gut flora," or "gut microbiome." Certain situations, such as taking antibiotics to treat an infection, may change the balance of microorganisms in the gut, allowing C. difficile to multiply and release toxins causing diarrhea, abdominal pain and fever, and in some cases, organ failure and death. Other factors that can increase the risk for CDI include age older than 65 years, hospitalization, a weakened immune system and a previous history of CDI. After recovering from CDI, individuals may get the infection again - often multiple times-a condition known as recurrent CDI. The risk of additional recurrences increases with each infection and treatment options for recurrent CDI are limited. The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI.

Rebyota is administered rectally as a single dose. Rebyota is prepared from stool donated by qualified individuals. The donors and the donated stool are tested for a panel of transmissible pathogens, however, as Rebyota is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. In addition, Rebyota may contain food allergens; the potential for the product to cause adverse reactions due to food allergens is unknown. The safety of Rebyota was assessed from two randomized, double-blind, placebo-controlled clinical studies and from open-label clinical studies conducted in the United States and in Canada.

The effectiveness of Rebyota was evaluated in an analysis of data from a randomized, double-blind, placebo-controlled, multicenter study. The analysis included 177 adults who received one dose of Rebyota and 85 who received one dose of placebo in this study. It also incorporated success rates from a different placebo-controlled study in which 39 adults received one dose of Rebyota and one dose of placebo and 43 adults received two doses of placebo. Success in preventing recurrent CDI was defined as the absence of CDI diarrhea within 8 weeks of administration of Rebyota or placebo. In a statistical analysis that took into account both studies, the overall estimated rate of success in preventing recurrent CDI through 8 weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%).


Seriously, Why the expensive intervention when a thorough end-to-end cleansing and probiotic solution probably works just as well? Still, it is a small step towards recognition by big medicine of a non-allopathic treatment.

Posted by: Thomas Schaefer at December 14th, 2022 8:17 AM
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