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June 30, 2014, Monday, 00:07 GMT | 19:07 EST | 03:37 IST | 06:07 SGT
Contributed by Millennium Traders

Fecal transplants from healthy patients into not-so-healthy patients affected with hard-to-treat intestinal infections could be a new cutting-edge treatment. One of the most common severe intestinal infections is Clostridium difficile - referred to as C-diff - a bacterial infection that causes nausea, cramping and diarrhea. C-diff afflicts nearly a half-million Americans annually and nearly 15,000 Americans die from the infection.

The New England Journal of Medicine in January 2013, published the first rigorous head-to-head study showing that fecal transplants were superior to antibiotics for patients with recurring C-diff. Additionally in recent years, a handful of doctors have published case studies on their use of fecal transplants to treat C-diff in patients, many reporting cure rates of nearly 90%.

The Food and Drug Administration is grappling with oversight of the low-cost fecal transplant treatment for the life-threatening infection that could cure up to 90% of patients often within a few days. Participating physicians take the stool of healthy patients to cure those with hard-to-treat intestinal infections. With many patients not responding to potent antibiotics - fecal transplants have emerged as an effective therapy against drug-resistant strains of the C-diff superbug. The procedure works because the healthy bacteria found in donors' feces can help fight off foreign infections.

While the majority of medical products and drugs from large drug or medical device developers face years in testing before being submitted for review by the FDA, fecal transplants follow a different path.

During May 2013, the FDA announced regulation of fecal transplants as an experimental drug, which means that doctors could only perform transplants under an FDA-approved research application. The so-called investigational new drug application must include detailed information on the drug to be tested, the study design and safeguards to protect patients. Assembling a single application can take months or years, even for large drugmakers. Doctors pushed back, saying the requirement would force them to turn away desperate patients. Within a few weeks, the FDA revised its position on regulation which reversed the enforcement of requiring doctors treating patients with drug-resistant C-diff providing that donors are properly screened and patients are informed that fecal transplants are still experimental.

Unlike many prescription medications, fecal transplants have minimal side effects. The treatment has been ruled as an "experimental drug". Regulators remain flexible over the treatment however, it does not meet the FDA's normal 'drug' monitoring process.

OpenBiome - a 'stool bank' located in Boston, Massachusetts since October 2013 - has managed to reduce costs down to nearly $250 per treatment by screening samples in bulk. OpenBiome has shipped over 300 stool samples, to date, in ready-to-use frozen preparations to 39 hospitals.

Mark Smith, founder of OpenBiome, says his group continues operating after having several productive discussions with the FDA. Regulators have encouraged Smith to set up a formal study in which hospitals that work with OpenBiome will contribute data on the safety and effectiveness of fecal transplants. Smith said, "They understand the importance of making treatment available for patients today, while making sure there is adequate oversight of the risks. We're actually totally on the same page."

Some patients afflicted with sever intestinal infections are resorting to websites, forums and online videos for their own, do-it-yourself methods for fecal transplants. This action has set off alarms for the FDA since fecal matter not properly screened can result in patients contracting HIV, hepatitis and other virus'. Because there are no long term studies for potential side effects from fecal transplants, the treatment should only be performed and monitored by medical professionals. Many ill patients who are unable to find a physician to perform a fecal transplant are resorting to websites such as for detailed instructions to try the procedure at home.

Dr. Lawrence Brandt of New York's Montefiore Medical Center, who has performed over 200 fecal transplants said, "We're dealing with something that is pretty close to miraculous." Brandt goes on to say, "FDA and some others are concerned about the long-term effects. But my point was these people are getting ready to die now. They are not going to survive long enough to develop the diseases you're afraid they're going to get."

Dr. Michael Edmond of Virginia Commonwealth University, who has performed fecal transplants for patients who travel from as far away as Ohio said, "Some of these patients are very desperate and they're not going to take no for an answer."

Catherine Duff, age 58 of Carmel, Indiana was suffering from her seventh C-diff infection which resulted in her going to the bathroom 20 to 30 times a day and making multiple trips to the hospital due to dehydration. Duff asked three different physicians if she could try a fecal transplant, but none were willing to perform the procedure, leaving her with no choice but to help herself. Duff said, "My quality of life had gotten to the point where I was beginning to think that it might be better to die." Following instructions found online Duff opted to perform her own fecal transplant. With the help of her husband, Duff created a solution from her husbands stool, mixing it with saline in a blender and administering it to her via an enema bottle. Duff said just four hours later she felt good enough to get up and go for a walk.

Duff now runs a nonprofit origination - the Fecal Transplant Foundation - which aims to raise awareness of the procedure as well as providing help to patients suffering from C-diff infection. Duff says she gets up to 15 emails a day from patients looking for a doctor or a donor. Some emails even inquire as to whether they can use a stool sample from their infants or pets. Duff says the unresolved status of FDA's oversight discourages more doctors from offering the treatment. "There are so many doctors who are suspicious that the FDA could change their mind at any given moment and decide to not exercise discretion," Duff says.

According to a list maintained by the Fecal Transplant Foundation, there are only about 100 physicians in the U.S.A. who offer fecal transplants. Additionally, there are various methods for performing the procedure including liquefying the stool and dripping it into the patient's colon via colonoscopy as well as other doctors using a tube that runs from the patients nose down into the stomach.