Two years ago, Kathleen, then 57, tearfully cried to a Washington committee on affairs that she had been infected eight times by the antibiotic-resistant Clostridium difficile bacteria (Clostridium difficile). But she said she got better after treating the gastrointestinal infection at home with an enema bag containing her husband’s stool mixture. Mark, a young microbiologist, was there to hear Catherine’s story, and he was very sympathetic to her plight. To help more patients like Catherine, he started a non-profit organization called OpenBiome, the first “stool bank” in the United States, which collects stool from healthy donors and distributes it to treat people infected with C. difficile. Now OpenBiome has made a new advance that makes this treatment even easier, called the Fecal Microbe Transplant. They have created a capsule containing fecal microbes that looks just like any other ordinary pill, but it’s a fecal pill. ”It’s a pretty obvious advance.” Mark said. C. difficile coexists with other flora in a normal, healthy body. When antibiotic use disrupts the competitive inhibition between C. difficile and other flora, the bacteria spread out in the intestines and produce toxins that cause persistent diarrhea. In the United States, the disease infects 450,000 people and causes 15,000 deaths each year. Most of these infections occur in hospitals and nursing homes. This nasty bacteria has developed resistance to common antibiotics. This is when fecal transplants are usually the last resort. The donor’s feces is injected into the patient’s intestines through an enema, colonoscope or nasal cannula. The healthy bacteria in the stool are in the intestine and work by replacing C. difficile and re-establishing a normal microbial environment. However, fecal transplants are expensive, time-consuming and invasive. “The first thing we thought about was that we wanted to get rid of the colonoscopy (invasion).” Mark said. Two studies have shown that freeze-dried, encapsulated fecal capsules, are effective for recurrent C. difficile infections, but it’s not known how to go about producing such capsules in large quantities. “The efficacy (during production) has to be maintained, and the temperature of the production plant has to be the same as the human body temperature the whole time (that is, it has to be hot-soaked).” Dr. Mark said. The challenge before us was how to maintain the biological activity of the feces. After a year and a half of work, OpenBiome has finally created a fecal capsule made of a microbial emulsion that is solid at room temperature and, when taken, liquefies and dissolves in the upper part of the small intestine. At a European scientific conference last month, clinicians reported after preliminary studies that a single dose of 30 of these fecal capsules cured 70 percent of patients with C. difficile infection, and that the cure rate rose to 94 percent when a second dose was given to patients who had not yet been cured. In contrast, in previous studies, fecal microbiology via colonoscopy was only 90% effective in treating C. difficile infections; antibiotics were less than 40% effective in treating C. difficile infections. Although fecal capsules have been manufactured, the dosage is relatively high, and taking these capsules filled with stool is not without risk. For example, if these intestinal flora enter the lungs, it can be life-threatening. Some argue that in the end it is not necessary to use the feces of healthy people to make pills. Seres Therapeutics Biotechnology, for example, is running a Phase II clinical trial called SER-109, where they are testing a four-pill regimen (four-pill regimen). Donor feces is treated with ethanol to obtain spore-forming anaerobic bacteria, which are then used to make the pills used in the four-pill regimen. Dr. Roger, CEO of Seres, said their company also produces a second generation of these pills, which contain microorganisms synthesized in a laboratory that are similar to those found in feces. pills that contain real stool, according to Dr. Roger, have no future. ”I don’t think anyone wants to eat (feces),” Dr. Roger said. “It’s really unbelievable that the whole country will be shipping feces in the future.” Dr. Mark and his colleagues say the encapsulated fecal capsules will help the research going on, with clinical trials throughout the country, and even the world, testing fecal microbial transplants, which could treat not only C. difficile infections, but other gastrointestinal diseases as well. One such trial is being done by Dr. Jessica, an internist in Boston who is trying to treat Crohn’s disease, obesity and C. difficile infections with fecal capsules. ”This reduces the time from assessment to administration and also allows for treatment of large numbers of patients, so stool capsules are the big thing,” she says, “especially for small diseases that require combination or maintenance therapy.” “What fecal capsules require us to do is to go into long-term research in this area, long-term maintenance therapy, which is much more relevant for the treatment of Crohn’s disease. We couldn’t have gone into these studies without fecal capsules.” Dr. Jessica said.