Fecal Transplantation Helps Kids w/ Ulcerative Colitis #UC study shows

Sounds promising from everything i've read and continue to read.  

• How do they get the fecal microbes into the person? According to the article, this is how it's done.  "To perform the transplant, a stool sample must be provided by a healthy adult, usually a family member or close friend. It is mixed with a saline solution and filtered to remove particles that could block the tube. It is given to the patient as an enema in a process that takes more than an hour." 

"Hey sheester, can you s*** in this cup please?"  How does one go about obtaining someones poop?  Hand them the bag with the sample cup and say "# 2 ..not 1."  If they look at you weird and they will, i'm certain.  Say "just do it, it's for a good cause"  

The ultimate probiotic: Unusual treatment helps kids with ulcerative colitis, study shows | MLive.com:

GRAND RAPIDS, MI – Life can be miserable for a kid who has ulcerative colitis.

Bouts of severe diarrhea, cramping and pain can cause them to miss school or avoid social activities. Medications to treat the condition can cause severe complications. The disease can delay growth. Some kids eventually have to undergo surgery to remove their colon.

That is why an alternative, drug-free treatment is raising hope – even as it raises eyebrows among those unfamiliar with it.

At  Helen DeVos Children’s Hospital, a pediatric gastroenterologist is getting good results for patients using fecal transplants. Stool from a healthy donor – often a parent - is given to the patient through an enema in an attempt to restore healthy bacteria in the child’s intestine.

“It’s the ultimate probiotic,” said Dr. Sachin Kunde.

Kunde conducted the first clinical trial in the country to study the use of fecal microbial transplantation on children with ulcerative colitis. Only 10 patients were involved in the trial, but the results were promising.

BY THE NUMBERS

Ulcerative colitis is a type of inflammatory bowel disease that affects the lining of the large intestine and rectum.• 1.4 million Americans suffer from inflammatory bowel disease
• 700,000 have ulcerative colitis
• One in four patients is diagnosed in childhood
SOURCE: CCFA 

The symptoms cleared up in three of the children – and they stayed symptom-free for at least a month. Another six saw improvements, which also lasted at least a month. For example, the number of daily bowel movements may have dropped from 10 to five, Kunde said. One child was unable to retain the enema.

The results of the study were published online by the Journal of Pediatric Gastroenterology and Nutrition and will be featured in the June print edition.

The study has stirred excitement among parents of children and young adults with ulcerative colitis, a form of inflammatory bowel disease that affects the lining of the large intestine or rectum.

“We had at least 50 patients in one year calling to be enrolled in the study,” Kunde said. “They want it because they don’t want medication. They think this is a fix.”

But Kunde balanced hope with caution. A larger study is needed to test the treatment’s effectiveness, he said. He has applied for funding for further research and is looking into whether the experimental treatment can be offered outside of a research setting.

Kunde said he first thought of using fecal transplants to treat ulcerative colitis during his fellowship at Emory University in Atlanta. They have previously been used experimentally to treat C. difficile infections.

Within a month of joining DeVos Children’s Hospital in 2011, he proposed the clinical trial to the Spectrum Health institutional review board. He also had to obtain approval from the Food and Drug Administration, because human stool is considered a drug and a biologic.

To perform the transplant, a stool sample must be provided by a healthy adult, usually a family member or close friend. It is mixed with a saline solution and filtered to remove particles that could block the tube. It is given to the patient as an enema in a process that takes more than an hour.

“We believe that the procedure may restore ‘abnormal’ bacteria to ‘normal’ in patients with ulcerative colitis,” Kunde said.

The pilot study involved 10 children and young adults, ages 7 to 20. They received a treatment a day for five days, and then their symptoms were evaluated.

Hospital staff made sure the patients did not see or smell the fecal transplant, which decreased anxiety and uneasiness about it. Kunde said awareness about the treatment is needed so people will readily see it as an acceptable option.

However, many struggling with severe symptoms of ulcerative colitis – adults and children – don’t need convincing, Kunde said. The disruption of life can be a significant psychological burden on patients and their families.

“People want this to be gone,” he said. “I don’t know if it will be gone or not. But it is a new hope for them.

“If we can help at least 30 percent of the patients, that is important.”

Contact Sue Thoms: Email. Twitter. Facebook.

http://www.mlive.com/news/grand-rapids/index.ssf/2013/04/fecal_transplant_-_the_ultimat.html

Soligenix- SGX203 was FDA "Fast Track" Designation to Treat Pediatric Crohn's Disease

Announcement of the FDA approval of SGX203 for children with mild to moderate Crohn's Disease. Soligenix SGX203 programme to treat paediatric Crohn’s disease receives US FDA fast track designation

Princeton, New Jersey Monday, November 12, 2012, 17:30 Hrs  [IST]

The US Food and Drug Administration (FDA) has granted “Fast Track” designation to Soligenix programme for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of mild-to-moderate paediatric Crohn’s disease. Soligenix has also previously received Orphan Drug Designation from the FDA for oral BDP as a treatment for paediatric Crohn’s Disease. Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX203 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission.  Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which implies an abbreviated review time of six months. “There are no FDA approved corticosteroid therapies for the induction treatment of Crohn’s disease in the paediatric population,” stated Christopher J Schaber, president & chief executive officer of Soligenix. “The FDA's action in granting fast track designation is an indication of SGX203's potential to address this debilitating, unmet medical need.  We look forward to working closely with the FDA to potentially expedite the development and NDA review process.” Crohn's disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. Crohn's disease can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine, called the ileum. The swelling caused by the disease extends deep into the lining of the affected organ. The swelling can induce pain and can make the intestines empty frequently, resulting in diarrhea. Because the symptoms of Crohn's disease are similar to other intestinal disorders, such as irritable bowel syndrome and ulcerative colitis, it can be difficult to diagnose. People of Ashkenazy Jewish heritage have an increased risk of developing Crohn's disease. Crohn's disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. However, approximately 30% of people with Crohn's disease develop symptoms before 20 years of age. Paediatric Crohn's disease is a subpopulation of approximately 80,000 patients 0-19 years of age in the United States.  Crohn’s disease tends to be both severe and extensive in the pediatric population and a relatively high proportion (25-40%) of pediatric Crohn’s patients have involvement of their upper gastrointestinal tract. SGX203 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. SGX203 is a two tablet delivery system (i.e., immediate and delayed release) of BDP specifically designed for oral use that allows for delivery of BDP throughout the small bowel and the colon. The FDA has previously awarded SGX203 Orphan Drug Designation for the treatment of pediatric Crohn's disease. Soligenix is a development stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well a developing several biodefense vaccines and therapeutics.

How it works - SGX203 is specifically formulated for oral administration as a single product consisting of two tablets. One tablet releases BDP in the upper gastrointestinal (GI) tract and the other tablet releases BDP in the lower GI tract. 

We will initiate a SGX203 development program for pediatric Crohn’s disease program in 2012. The objective of developing SGX203 for pediatric Crohn’s is to make available a corticosteroid option with less toxicity than the current standard therapy prednisone. 

Soligenix SGX203 programme to treat paediatric Crohn’s disease receives US FDA fast track designation:

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