A medical solution aimed at malnourished children

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The THRIVE (transfer of healthy gut flora for restoration of intestinal microbiota via enema) trial is a small phase 1 study that will investigate whether faecal transplants can help severely malnourished children who fail to develop even after their nutritional needs are met.

Globally, about 35% of children who have severe acute malnutrition fail standard therapy, which includes specially formulated high-calorie food, says UCT’s Shrish Budree, a research fellow at OpenBiome and one of the investigators on the trial.

"These kids don’t achieve their full growth potential and end up stunted, with an increased risk of infections and mortality," he says.

"In the longer term, they are likely to be less productive adults, which has bigger implications for society at large. There is currently no alternative for the kids who don’t respond to standard therapy."

Read more: https://www.businesslive.co.za/bd/life/2018-08-29-a-medical-solution-aimed-at-malnourished-children/

WASTE NOT: Can poo transplants cure malnutrition?

Sunday Times

"For physicians and researchers involved in the Cape Town trial, dubbed Thrive, healthy faecal matter is like gold. They believe it could be a fix for the 40% of severely malnourished children who do not respond fully to nutritional feeding.

SA will be the first country on the continent to test if such transfers can prevent stunting from malnutrition, which impairs mental development and dramatically increases child mortality rates. Malnutrition is common in SA and affects 19-million children globally."

 

Read more:

https://times-e-editions.pressreader.com/sunday-times/20180826/textview

Do You Have the Right Stuff to Be a Stool Donor?

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“To do something as simple as going in and making a stool donation, and know that it can literally change someone’s life from one day to the next when they have a disease like C. diff, where they can’t even leave their house and the next day they can go about things fairly normally — to see that impact makes me feel good,” he said.

 

Read more:

https://www.nytimes.com/2018/06/05/well/live/fecal-transplant-stool-donor.html

Faecal transplantation: do not try this at home

An important concern relates to the transplanted stools themselves. Majdi Osman is clinical programme director at OpenBiome, the largest stool bank in the USA. “We exclude 97% of volunteers”, he told The Lancet Gastroenterology & Hepatology. [...] The vast majority of exclusions occur at the clinical interview. “Only physicians can collect the material, and we vet all the centres who apply to make sure that they have the facilities to administer it safely”, adds Osman.

When Poop Becomes Medicine (VIDEO)

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"Fecal transplants—where doctors try to cure sick people of various ills by giving them the stools of healthy donors—have been used since at least fourth-century China, according to texts that make reference to 'yellow soup.' The unusual treatment has been rediscovered many times since, but it’s finally starting to enter the medical mainstream. Partly, that’s because of a surge of interest in the microbiome—the trillions of microbes that share our bodies. Partly, it’s because many well-conducted studies have shown that fecal transplants are incredibly effective at treating Clostridium difficile—a nasty, hardy bacterium that causes severe, recurring, and potentially fatal bouts of diarrhea."

See the video here.

Experts call for new approach to regulating fecal transplants

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"A paper today in Science calls for a better way to regulate an increasingly popular method of treating recurrent Clostridium difficile infection (CDI).

The method, known as fecal microbiota transplantation (FMT), involves the transfer of stool from a healthy donor—via colonoscopy, nasogastric tube, or enema—into the colon of a patient who has recurrent CDI to re-introduce healthy bacteria into the gut. While still an investigational treatment, FMT has produced strong results in several small clinical trials in recent years, with cure rates as high as 90%.

A growing number of physicians are turning to it as an alternative to antibiotics—which can contribute to re-infection by wiping out the beneficial gut bacteria that keep C difficile bacteria in check—and several medical societies have said it should be a standard of care for patients with multiply recurrent CDI.

But proponents of FMT are concerned that the unsettled regulatory landscape may be preventing the procedure from being more widely accessible."

Patients Want Poop Transplants. Here's How to Make Them Safe

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“'The way the regulations are written now, everything is being done under enforcement discretion,' says Diane Hoffman, a professor of health law at the University of Maryland, and first author on the Science paper. The FDA is just choosing to bend the rules for C. diff. patients. But the agency could just as easily unbend them, whenever it wants. Which is why Hoffman and her colleagues are suggesting transplants used for C. diff be regulated as a 'practice of medicine' rather than a drug, when the stool comes from someone the patient or physician knows, i.e. not a stool bank. Then it would only be subject to state, rather than federal regulation. More patients could then access the treatment—which has cure rates above 80 percent—regardless of market winds or agency whims. All other uses of FMT would still be subject to formal clinical trials overseen by the FDA."

Read more.

So You Want To Be A Sh*t Donor? (AUDIO)

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"OpenBiome is changing lives thanks to the increasing evidence of the crucial impact of gut health and the microbiome on our overall health – with potential applications in a range of areas, from Parkinson’s to mental health. The company is pioneering research in this field, currently supporting 14 clinical trials.

We wanted to get to the bottom of this fascinating new medicine, so we caught up with founder Mark Smith to get down and dirty on stool banks, fecal transplants, and how this research is revolutionising medicine."

7 Startups Making The World A Better Place

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"It’s one of the most exciting areas of science right now, the microbiome. Trillions of organisms define your own unique makeup, and a large portion of these microbes is found in the gut, which forms an integral part of your immune system. This area, if tweaked, has the ability to transform your health. The race is now on in biomedicine to help deliver a new wave of treatment based on this area. One of those startups spearheading research and interest in this is OpenBiome, founded by Mark Smith and James Burgess, a startup based out of Massachusetts dedicated to expanding safe access to fecal microbiota transplantation (FMT) through its public stool bank and catalyzing research into the human microbiome."

Verify: The healing power of poop (VIDEO)

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"So, are we so obsessed with being clean that we're making ourselves sick? The science says yes:

  • Germs and bacteria are misunderstood.
  • Some bacteria are bad, but most help us maintain a healthy balance in the microbiome.
  • In our quest to kill germs, we have traded infectious diseases for chronic ones that are very hard to treat. And that’s why we’re turning to therapies like the fecal transplant.

The concept behind the poop transplant is very basic. A donor, who’s been through a rigorous screening process, provides a stool sample that’s loaded with his or her naturally healthy bacteria. It's then implanted into the patient who has a bacterial disease.

So far, doctors have done almost 30,000 fecal transplants for C. difficile. But now there are promising trials underway to treat obesityulcerative colitis and even autism."

Vice News (VIDEO)

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"Fecal transplants have the power to revolutionize medicine, but hospitals need raw materials. At Open Biome, the country’s first independent stool bank right outside Boston, donors earn $40 for each sample.  The clinic, however, approves less than 3 percent of applicants. VICE correspondent Thomas Morton visited the stool bank and made a deposit."

Click here to watch the video.

Give a Sh*t

With its 2.8 percent acceptance rate, OpenBiome is almost twice as selective as Harvard College. You might make it through the initial evaluation—a short survey, a 200-question form, and a clinical visit—safe in the belief that your poop is a solid 10, but you might find out through the subsequent blood and stool analyses that your bacteria could harm, not help, the recipient.

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It's Time for FDA-Approved Poo

In an op-ed in the Huffington Post, Catherine Duff, founding president of the Fecal Transplant Foundation and Carolyn Edelstein, director of outreach and public affairs at OpenBiome, reflect on OpenBiome's announcement of its collaboration with Finch Therapeutics and on how an FDA-approved microbiota treatment for recurrent C. difficile infection would transform patient care. 

View the op-ed here. 

TEDMED (VIDEO)

With the rise of antibiotic resistance, the search is on for therapies that can combat bacterial infections without engaging in an evolutionary arms race.

OpenBiome is a nonprofit stool bank that aims to expand safe access to fecal transplantation for patients with recurrent C. difficile and to catalyze research on the microbiome’s role in human health. OpenBiome provides clinicians with rigorously screened, ready-to-use stool preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile.

Since 2013, OpenBiome has partnered with over 700 healthcare institutions across all 50 states and 6 countries to deliver over 14,000 treatments for recurrent C. difficile. Its portfolio includes 50% of all U.S. trials exploring the use of fecal transplants in new diseases. Watch the TED Talk here.

VICE on HBO (VIDEO)

For years, medical science was powerless against one of the most of severe intestinal infections. But a new treatment shows tremendous promise -- if patients aren't too squeamish to try it.

Fecal transplants use the stool from a healthy person to repopulate life-sustaining bacteria in the colon of the patient. This technique is so effective that researchers are testing its potential to treat disorders far beyond the digestive tract, pointing to breakthrough treatments for a broad range of the most stubborn diseases.

VICE reports from the labs and lavatories where this medical revolution is taking place. Watch the full video or the debrief.

Banking on stool despite an uncertain future

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Tina Amirtha from Science discusses the regulatory future of fecal transplants, and how universal stool banks like OpenBiome could continue to make an impact. Here's an excerpt from the article:

"Whatever the commercial future of FMTs, the stool banks say they’ll have other work to do. OpenBiome may focus more on research, Edelstein says. Besides stool, OpenBiome provides guidance on experimental designs, safety protocols, and IND applications. The Leiden bank seeks to advance science as well. It just started a research collaboration with Vedanta Biosciences, and it plans to study whether fecal transplants should be given to C. difficile patients at an earlier stage. “Now, patients receive [an] FMT when they have tried all the other options,” Kuijper says. “But more can easily benefit.” 

Click here for the full article. 

The Demand for Poop

"Passing a stool-screening test may be the hardest part of the process. “It’s actually more difficult than getting into Harvard,” says Smith. Only about four per cent of people who volunteer to be stool donors pass the three-step screening process, which involves a questionnaire, and stool and blood test, meant to rule out the presence of any known pathogens. (It’s easier to pass the mail-in variety lab test, which collect much less information.)

Despite the rigorous screening process, OpenBiome still manages to collect enough stool to supply 371 clinics and hospitals in 48 states and five countries. The bank collected its first sample in October 2013 and treated six patients by the end of the year. In 2014, they treated 2,000 patients, and by now they’ve provided stool for 5,419 treatments, and counting. “I didn’t really anticipate that it was going to grow as quickly as it has,” says Smith. And while there’s a distinct ick factor tied to his product, Smith says the stuff sells itself. “What’s kind of crazy about this thing is I sent out one email to a group of clinicians who were doing fecal transplants, and since then we’ve just been responding to requests.”"