EiR Blog

Biotech startup Rebiotix has raised $25 million in capital to fund clinical trials of its fecal-transplant technology. The Roseville-based company raised the funding from individual investors, CEO Lee Jones said. Rebiotix transplants bacteria from healthy stool into patients suffering from C. difficile, a bacterial infection that’s typically acquired during hospital stays. In addition to clinical trials, the recent round of funding will go toward research and development and working capital, Rebiotixsaid. The company will present results from an earlier clinical trial in October. Last year, the Food and Drug Administration accepted Rebiotix’s productinto its fast-track program, which could expedite the technology’s approval for sale. Rebiotix has now raised $30 million since launching in 2011.Katharine Grayson covers med tech, clean tech, technology, health care and venture capital.   Read More: http://www.bizjournals.com/twincities/blog/in_private/2014/08/fecal-transplant-startup-rebiotix-clinical-trials.html?s=image_gallery       ...

Fecal transplants let packrats eat poison Jul 21, 2014   A captive desert woodrat, also known as a packrat, stands on a rock near branches from a toxic creosote bush. Credit: Kevin Kohl, University of Utah.                                                           ---------------------------------------------------------------------------------------   Woodrats lost their ability to eat toxic creosote bushes after antibiotics killed their gut microbes. Woodrats that never ate the plants were able to do so after receiving fecal transplants with microbes from creosote-eaters, University of Utah biologists found.   The new study confirms what biologists long have suspected: bacteria in the gut – and not just liver enzymes – are "crucial in allowing herbivores to feed on toxic plants," says biologist Kevin Kohl, a postdoctoral researcher and first author of the paper published...

(by the way....i'm not ordinarily a Daily Mail reader :-)))      Vicky Grant was in a work meeting when once again she was gripped by painful stomach cramps.       'I didn't know whether to make a dash to the bathroom or just sit it out and hope it would pass,' recalls Vicky, 43, a medical librarian, who is divorced and lives in Sheffield. 'I was coping with up to seven bouts of diarrhoea a day and it was really taking its toll on me. 'I decided to risk it and stay put, but I was concentrating so hard on staying in control that everything being said in the meeting passed over my head.   'I felt bloated, tired and fatigued. My weight was below 7st (I'm 5ft 3in). I'd lost so much weight and looked terrible - I'm sure people thought I had anorexia. It was also...

Nov. 22, 2013 — Research jointly conducted by investigators at Institut Gustave Roussy, Inserm, Institut Pasteur and INRA (French National Agronomic Research Institute) has led to a rather surprising discovery on the manner in which cancer chemotherapy treatments act more effectively with the help of the intestinal flora (also known as the intestinal microbiota). Indeed, the researchers have just shown that the efficacy of one of the molecules most often used in chemotherapy relies to an extent on its capacity to mobilize certain bacteria from the intestinal flora toward the bloodstream and lymph nodes. Once inside the lymph nodes, these bacteria stimulate fresh immune defenses which then enhance the body's ability to fight the malignant tumor.   Results of this work are published in the journal Science on 22 November 2013. The intestinal microbiota is made up of 100,000 billion bacteria. It is a genuine organ, since the bacterial species that comprise it...

21.11.2013 - (idw) University of Gothenburg Food transit through the small intestine affects the body's absorption of nutrients and, consequently, our health. The discovery that food transit time is regulated by a hormone indicates new ways to increase the intestinal absorption of nutrients, and thus potentially treat malnutrition. One of the tasks of the gut microbiota is to break down essential nutrients from our diet to provide a usable energy source in the colon. Researchers at the Sahlgrenska Academy, University of Gothenburg, have now shown that lack of energy in the colon leads to increased release of a hormone primarily associated with appetite control and insulin secretion, GLP-1. Importantly, they also showed that the released GLP-1 regulates how quickly food passes through the small intestine. These findings may open up new possibilities to treat malnutrition and malnutrition-related diseases. Food transit through the small intestine is a complex balancing act, in...

Bacteria extracted from human poop are the main ingredients of a new pill that may help treat patients who have difficult-to-cure intestinal infections, according to a new study from Canada. The study involved 32 patients with recurrent Clostridium difficile, a bacterial infection that causessevere diarrhea and can be life-threatening. The infection can occur after people take antibiotics, which often wipe out "good" bacteria and leave the door open for harmful bacteria like C. difficile to flourish in the gut. Some patients, like those in the study, become trapped in a cycle of antibiotic treatment and recurrent C. difficile infection,said study researcher Dr. Thomas Louie, professor of medicine at the University of Calgary in Alberta. Study participants had suffered at least four bouts of C. difficile prior to the study. But after taking the pills — which repopulate the gut with "good" bacteria — nearly all participants were free of C. difficile infection, and have not had another infection since then,...

  TEL-AVIV, Israel, Oct 15, 2013 (GLOBE NEWSWIRE via COMTEX) -- -- The retrospective study, presented at the 2013 American College of Gastroenterology (ACG) Annual Scientific Meeting, demonstrated strong results with a high remission rate of 80%   -- RedHill's RHB-104 is a new and improved proprietary single-pill formulation of the combination of active ingredients used in the retrospective pediatric study         -- The independent, single-site, retrospective pediatric study was conducted in Australia by Prof. Thomas Borody, MD, a member of RedHill's Advisory Board, a renowned researcher in gastrointestinal diseases and the developer of RHB-104   -- RedHill has recently initiated a Phase III study in the U.S. with RHB-104 for the treatment of Crohn's disease in adult patients and plans to initiate a second Phase III in Europe by mid-2014     RedHill Biopharma Ltd. RDHL +2.00% (tase:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily...

Taking pills containing a concentration of fecal bacteria may knock out recurrent bouts of Clostridium difficile infection by rebalancing gut bacteria, according to a study presented on Friday at IDWeek 2013. Fecal transplantation uses the feces from healthy donors to treat patients with an imbalance of bacteria in their gastrointestinal system, such as in patients infected with C. difficile. According to published reports, fecal transplantation is effective in nine out of 10 patients. The treatment is typically delivered by enema, colonoscopy or nose tube. The new research suggests a less-invasive pill approach could be an effective and viable delivery method. “Recurrent C. diff infection is such a miserable experience and patients are so distraught that many ask for fecal transplantation because they’ve heard of its success,” Thomas Louie, the lead author of the study, said. “Many people might find the idea of fecal transplantation off-putting, but those with recurrent infection are thankful to have a...

I've been keep a note of articles I read relating to intestinal bacterial Flora & Fauna and thought i'd share some of the links with you all:    Clostridium Difficile- Treatment and Trials with FT: Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile (January 2013)  http://www.nejm.org/doi/full/10.1056/NEJMoa1205037    Hope floats: Fecal transplants cure >90% of recurrent C. difficile http://pulmccm.org/2013/randomized-controlled-trials/hope-floats-fecal-milkshakes-cure-recurrent-c-difficile-rct-nejm/  U.S. Company uses feces to treat infection (June 2013) http://www.bizjournals.com/twincities/print-edition/2012/06/29/startup-fecal-matter-treat-infection.html?page=all  Medical team uses fecal transplants to cure tough GI infections (May 2013)  http://www.leadertelegram.com/features/health/article_a259ee58-cd99-571e-b08d-4fafda3b8432.html  FMT Clinical Study Results - New England Journal of Medicine (January 16, 2013) Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile http://www.nejm.org/doi/full/10.1056/NEJMoa1205037    Fecal Transplant Beats Vancomycin For C. difficile (March 2013) http://www.idse.net/ViewArticle.aspx?d=Bacterial+Infections+/+MRSA&d_id=211&i=March+2013&i_id=941&a_id=22831    Colitis- Treatment and Trials with FT: Children with ulcerative colitis benefited from fecal transplants (May 2013)  http://www.ncbi.nlm.nih.gov/m/pubmed/23272525/  Microscopic colitis and small intestinal bacterial overgrowth--diagnosis behind the irritable bowel syndrome? http://www.ncbi.nlm.nih.gov/m/pubmed/23272525/   A Spectrum...

http://www.voanews.com/content/fecal-transplants-used-to-cure-intestinal-disorders/1723974.html

  July 9, 2013 Common molecules made by bacteria in the gut may act as chill pills for the immune system. Molecules secreted by intestinal bacteria work to prevent misplaced immune attacks in inflammatory bowel diseases like colitis, a new study finds. “It is a huge advance,” says Sarkis Mazmanian of Caltech. “This opens up the notion that a very easy and potentially very safe therapy for inflammatory bowel disease could exist.” Decades of research have hinted that microbes play a role in immune-related diseases such as obesity, allergy, inflammatory bowel disease and colon cancer. But scientists have had difficulty pinpointing direct links between the bacteria in the gut and the army of immune cells that live there.   Some researchers have focused on individual microbial species among the gut’s teeming hordes to see how they affect the immune system. But Wendy Garrett’s team at Harvard University decided to look instead...

  Last week, the US Food and Drug Administration (FDA) quietly announced it would be backing off a previous proposal to require fecal microbiota transplants to be conducted under either an approved biologics license application (BLA) or investigational new drug (IND) application. Now, however, it has announced the approval of fast track designation for an investigational product sponsored by Minnesota-based Rebiotix, potentially one of the first – if not the first – products to seek formal approval as an FMT product. Background An FMT is a transplant of carefully-selected bacteria found in ones' colon to another person to fight Clostridium Diffiicile (C. Diff), a notoriously hardy strain of bacteria that kills an estimated 14,000 people each year. Various published research has identified the FMT procedure as being one that can fight off C. diff infections by introducing so-called "good bacteria" back into a person's body. The idea is to overload the gastrointestinal tract...

  Posted: 17 July 2013  After deciding in June 2013 to begin fast-tracking fecal transplant procedures by scrapping an earlier requirement that would have mandated an approved Investigational New Drug (IND) application, the US Food and Drug Administration (FDA) had just released a new guidance document clarifying the enforcement approach it informally announced in June. Background Fecal transplants are a relatively new innovation involving the transfer of either fecal matter or the bacteria found within fecal matter from a healthy patient to a sick one. Various published research has identified the procedure as being one that can fight off Clostridium difficile infections by introducing so-called "good bacteria" back into a person's body. The idea is to overload the gastrointestinal tract with enough of the good bacteria to overwhelm the C. diff, thereby ending the infection. One device, known affectionately as either the "RoboGut" or the "RePoopulation Station," is essentially a small manufacturing facility...

How Fake Poop Can Cure Patients’ Stomach Ailments     RePOOPulate: How Fake Poop Can Cure Patients’ Stomach Ailments Using something called a "robo-gut," scientists have made ersatz fecal matter to help fix stomach ailments. It’s not the most glamorous invention, but if it works…    Fake poop: It’s not just something that elementary school kids love to play with. It can also keep people healthy. Emma Allen-Vercoe, a microbiologist at the University of Guelph in Ontario, revealed in early January that her synthetic poop, dubbed rePOOPulate, can cure gastrointestinal infections caused by a bacterium called Clostridium difficile (CDI) that can trigger severe diarrhea. Usually antibiotics can wipe out CDI, but in particularly bad cases, they don’t work. Allen-Vercoe’s artificial stool study, published in a new peer-reviewed journal called Microbiome, comes after years of the microbiologist’s work on a “robo-gut," a glass and stainless steel system that mimics the large...

  The phase I clinical trial of the procedure was conducted by members of the Pediatric Specialty Department of the Spectrum Health Medical Group at Helen DeVos Children's Hospital, the first in the country to study FMT in children. FMT is a process that involves infusion of human stool from a healthy donor into the intestine of the patient in an attempt to restore healthy microbial flora in the intestines of the patient. When used to treat a disease, human stool constitutes a drug and a biologic. Therefore, an investigational new drug approval was obtained from the United States Food and Drug Administration (FDA) to utilize FMT for treating ulcerative colitis in this trial. The study results have been published online by the Journal of Pediatric Gastroenterology & Nutrition and will be featured in the June print edition. "FMT has been proposed as a promising new treatment option for recurrent...

  Only one of five patients with moderate to severe ulcerative colitis (UC) who were treated with fecal transplantation (FT) experienced clinical and endoscopic improvements following the procedure, according to an abstract presented at the 2012 United European Gastroenterology Week (abstract P374). Lead investigator Walter Reinisch, MD, associate professor in the Division of Gastroenterology and Hepatology at the Medical University of Vienna, Austria, conducted the procedure in two women and three men with moderate to severe UC who were resistant to previous other treatments. All participants were undergoing immunosuppressant therapy before FT and discontinued treatment before transplantation. All patients received antibiotics and probiotics for five to 10 days before the procedure and underwent a single bowel lavage immediately before transplantation. Healthy adult fecal donors were screened for enteric pathogens and viral diseases. Dr. Reinisch simultaneously administered a saline-diluted fecal solution via a nasojejunal tube (median 23.8 g) and an enema...

  Everyone's skin carries acne-causing bacteria, of which there are 'good' and 'bad' strains Having too much 'bad' bacteria is what causes acne Findings could pave the way for new treatments     Even celebrities cannot escape the acne-causing bacteria: Cameron Diaz succumbs to an outbreak of spots     But the days of spots may now be numbered after scientists discovered why some people are more prone to them than others.    The researchers, from UCLA, have discovered more about the bacteria that live on the skin and cause acne.   They have found that this bacteria contains ‘bad’ strains which cause pimples and ‘good’ ones that may protect the skin.   Having too much 'bad' bacteria is what causes spots, they say.   This is rather like an imbalance of good and bad bacteria in the gut causing digestive issues.  It is not yet clear why some people have...

  Editor’s Comment: This study builds on previous research demonstrating abnormal bacterial gut flora in ME/CFS patients. In addition to causing numerous gastrointestinal symptoms, prior studies have found that abnormal gut flora in ME/CFS patients is linked to cognitive dysfunction (Maes and De Meirleir). This is the first study to demonstrate a complete remission of symptoms in a significant percentage of ME/CFS patients after the normalization of gut flora. The GI microbiome and its role in Chronic Fatigue Syndrome:  A summary of bacteriotherapy By Thomas Borody et al ~Source: Journal of the Australasian College of Nutritional and Environmental Medicine, December 2012 Abstract Introduction: Chronic Fatigue Syndrome (CFS) has a complex and multifactorial etiology making treatment and definitive diagnosis, currently made through exclusion, difficult. Current therapies, such as cognitive behavior therapy and graded exercises, are inadequate and targeted to address symptoms, rather than the underlying disease pathology. Increasing evidence implicates the microbiota of the...

  Too much antibiotic can decimate the normal intestinal microbiota, which may never recover its former diversity. That, in turn, renders the GI tract vulnerable to being colonized by pathogens. Now researchers from Memorial Sloan-Kettering Cancer Center, New York, NY, and Centro Superior de Investigación en Salud Pública, Valencia, Spain, show that reintroducing normal microbial diversity largely eliminated vancomycin-resistant enterococci (VRE) from the intestinal tracts of mice. The investigators showed further that the findings may apply to humans.   The research is published in the March 2013 issue of the journal Infection and Immunity. The reduced diversity of microbiota wrought by antibiotics "allow[s] VRE to invade and thrive in the intestine, suggesting that bacterial species that are wiped out by antibiotics are key to preventing colonization by VRE," says first author Carles Ubeda of the Centro Superior de Investigacion en Salud Publica, Valencia, Spain. "We hypothesized that repopulating the mice'...

An antibiotic created from human sweat might fight off hospital superbugs and deadly strains of tuberculosis, scientists reported in Proceedings of the National Academy of Sciences. The researchers, from Scotland, Germany, France and Spain explained that a protein found on human skin - Dermcidin - is activated in sweat (slightly acidic and salty environments) and kills harmful microbes by perforating their cell membranes. Dermcidin is a natural protein, part of our natural defences, that is present on our skin when we sweat. The authors wrote thatunderstanding how these natural defences work could help researchers design effective alternatives to conventional antibiotic medications. Until now, the scientific community could not fully explain how proteins produced by animals and plants have been fending off harmful bacteria, viruses and funguses for millions of years. If we can eventually unravel how proteins such as dermcidin work, we may be better equipped to fight off infections which...