Purified Fecal Probiotics Kill Clostridium difficile Infections
Clostridia infections can be deadly. Literally. Clostridium difficile infections cause about 29,000 deaths in the U.S. every year.
Many of these infections are picked up in the hospital. These are called hospital-acquired infections. Many of these infections are also resistant to antibiotics.
Nonetheless, antibiotics are typically used to treat C. difficile infections. As a result, many C. diff infections will subside with antibiotics only to grow back with a vengeance.
There have been some recent studies showing that fecal transplants are effective in treating C. difficile infections. And a lot of people have been getting on the fecal transplant bandwagon.
I haven’t. Besides the yuck factor: The problem I and many other microbiome researchers see with fecal transplants is the possibility of transmitting infections with fecal transplants.
Why fecal transplants are a bad idea
A fecal transplant is basically taking someone’s stool and inserting it into the intestines of someone else. Some purification may be done before the transplant, but not that much.
Yes, the donor’s stool might have some really good bacteria if the person is healthy. But their stool may also contain cultures of bacteria and other immune cells that can cause damage in another person. Note there are trillions of bacteria that live in our intestines. Some are good and some are bad, especially if they get out of hand.
In one gut, those bad species may be controlled by the good guys. But put into the intestines of someone who doesn’t have as many strong species, those bad guys can easily get out of hand. We’ve also showed evidence that fecal transplants can produce fevers and other infections.
Fecal transplants are not always therapeutic either.
For example, in a 2017 study, researchers from Cornell and NYU tested fecal transplantation with 20 patients with ulcerative colitis.
Only four of the patients saw remission by week four of the study. That’s only 20 percent. And while 7 had a positive clinical response, that still leaves a majority of 13 patients with no response.
The researchers noted that:
“Donor composition correlated with clinical response and further characterization of immunological parameters may provide insight into factors influencing clinical outcome.”
The intestines are very complex, and unique to each of us. There are still a lot of variables to work out when feces is transplanted from one person to another. Our bacteria species are rather unique to us over a lifetime. Much more unique than a blood type. And the potential for infection later is increased by this factor as well.
Fecal transplants have shown more success in treating Clostridia infections. But the risk is still there. For example, a 2017 study from Spain studied 12 patients with C. diff infections.
Shortly after the fecal transplants, 11 out of 12 saw remission from their C. diff infection. The other person responded after successive treatments.
Without a doubt, this is a great result. However, two of the 12 people died during the follow-up period. That means 17 percent of the research population died within a year or so of the study.
The researchers say the deaths were unrelated to the fecal transplants. But how do they know this for sure? So many things can be potentially transferred in a fecal transplant. And our gut bacteria can effect many elements of our health, including the liver, the heart, the brain and immune system.
The clean answer to fecal transplants
A company called Seres Therapeutics has developed a better method of utilizing probiotics found in healthy intestines. The company has done extensive research on human microbiome cultures found in healthy people and those with C. difficile infections.
The company developed a method of purifying and isolating certain species of bacteria found in human intestines. In this case, the company produced a blend of 50 species of bacteria initially derived from fecal matter of healthy people.
The company purified and fractionated the effective cultures to separate them from other potential pathogens found in feces samples. Purification processes included using ethanol to kill of active microbes. They conducted tests on each purified batch in order to be sure there were no unwelcome buggers.
This process also better isolated those specific bacteria that combat the C. difficile.
The purified species of bacteria were then heated, washed and analyzed for spore content. They found no vegetative microbes from any of the remaining purified batches. The purified, dehydrated spores were put into capsules.
Here is a summary of the process:
“SER-109 is composed of approximately 50 species of Firmicutes spores derived from stool specimens from healthy donors. After demonstrating the preclinical efficacy of SER-109 in rodent CDI models, we formulated it for oral delivery in humans based on the hypothesis that spore-forming organisms would compete metabolically with C. difficile for essential nutrients and/or bile acids. In addition, spore purification with ethanol reduces the risk of transmission of other potential pathogens. This initial study was designed to evaluate the efficacy and safety profile of SER-109 for CDI prevention in patients with recurrent infections and to measure alterations in the gut microbiota.”
This statement, from a clinical research paper, illustrates that I am not alone in my concern about the “risk of transmission of other potential pathogens” resulting from fecal bacteria.
Treatments prevent C. diff relapse
The researchers tested 30 patients with recurrent Clostridium difficile infections. Two different doses of the protocol were given to 15 of the patients for two days. The researchers then gave the other 15 patients a lower dose.
The initial doses averaged 1.7 billion spore colony forming units (SCFUs – like CFUs). The second round of dosing to the second group averaged 110 million SCFUs. Each group was given this dose for only two days.
The researchers found that 87 percent of the patients (26 out of 30) achieved resolution of their C. difficile infections immediately. Then three of the four tested negative for C. difficile after 8 weeks.
This means that 29 of the 30 patients were cured of their recurrent C. diff infections. That is an astounding 97 percent effective rate.
Continued development for FDA approval
Seres Therapeutics is now in the process of enrolling a Phase Ib clinical study. This will have a placebo group and several different doses of a similar probiotic supplement.
The aim is to get the probiotic supplement approved by the Federal Drug Administration (FDA) for treatment of C. difficile infections. The company is also testing a similar protocol for ulcerative colitis.
Most probiotic supplements cannot be labeled to treat specific diseases because they are supplements and not medicines. There may be plenty of research, but the manufacturer must undergo phase I, II and III studies to prove the effectiveness of the medicine.
If you have a recurrent C. diff infection, talk to your doctor about this option. Perhaps he can help you get enrolled in the next Seres study.
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