“粪便银行”：救人拿钱两不误

如果你年龄小于50岁，排便规律，而且愿意每天去美国麻省麦德福德跑一趟，那么没准你可以每天得到40美元的外快，而你需要做的事情只是生产便便。
　　要想得到这笔收入，请拜访“开放生物群”（OpenBiome）。它是全美唯一的独立非营利性“粪便银行”，初建于2012年，由麻省理工学院博士后马克•史密斯（Mark Smith）创立。开放生物群向33个州的122家医院提供粪便样本用于肠道菌群移植治疗。
　　为什么要捐粪便？
　　粪便库收集的这些粪便样本主要用于治疗一种特殊的肠道感染——艰难梭菌感染。这种疾病的主要症状是腹泻，它的出现往往与肠道菌群的失调有关。艰难梭菌感染每年可导致1.4万美国患者死亡。由于抗生素耐药问题愈发严重，这种肠道感染也变得更加难治和容易复发。而对于药物治疗难以奏效的艰难梭菌感染患者而言，移植健康人粪便中的肠道菌群是目前最理想的治疗方法。
　　经典的粪菌移植方法是通过口鼻或肛门插管，将新鲜粪便送达肠道。这样新鲜大便中的肠道细菌就可以在被移植者体内重建肠道菌群，缓解肠道感染。为了保证治疗效果，既需要粪便提供者拥有健康的肠道菌群，又需要保证粪便新鲜以维持细菌的活性，而“粪便银行”就是在这样的需求下应运而生的。
　　捐献过程并不容易
　　捐粪便换钱听起来似乎是极其轻松愉快的致富之路，而事实上，想要成为一名粪便有偿捐献者并不是那么容易。为确保粪便质量合格，捐献者必须首先填写由120个问题组成的调查问卷，交代自己的既往病史、旅行经历以及近期使用抗生素情况。接下来还要进行粪便检查，确保肠道菌群健康、不含高危病原体。然后，还要抽取血样，进行甲乙丙型肝炎、梅毒、艾滋病等传染病检查。全套筛查下来大约要花上1000美元，所幸“粪便银行”会承担全部费用。
　　筛查合格之后，捐献者就可以正式上岗了。开放生物群希望粪便捐献者可以在60天内进行频繁的捐献，在此期间，捐献者需要每周至少来机构4次，并把他们的“捐献样品”投入坐便器上一个帽子形状的收集器里。每成功捐献一份样本，捐献者就可以得到40美元报酬。一次采集的粪便标本通常可以用于4~5位患者的治疗。收集到的粪便样本会在-80℃条件下保存，并放在干冰上运输。开放生物群的工作人员表示，这些冷冻便便的疗效与新鲜的一样好，而且它们更加方便，“保质期”更长（可达6个月），还可以储存起来以备不时之需。
　　

　　提供50克粪便，即可让一位患者得到治疗。图片来自：OpenBiome
　　“粪便银行”的目标人群主要是年轻人，因为他们通常更加健康。这里的捐赠者平均年龄大约在30岁上下。附近塔夫脱大学的学生们也为粪便库贡献良多。为了鼓励人们捐献，“开放生物群”在例行报酬以外还设置了“每月捐献最多奖”、“单次捐献最多奖”之类的奖项，并向优秀的捐献者们授予“拉屎之王”（King of Poop）、“小翔维尼”（Winnie the Poo）之类逗趣的称号。
　　FDA的管理难题
　　“粪便银行”项目听起来十分美好，不过在类似医疗服务的监管方面依然存在不少争议。
　　如何对粪菌移植进行恰当的评估和监管，这是美国食品药品监督管理局（FDA）面临的一大难题。FDA指出，虽然在不少案例中，这种治疗手段都显示出了良好的效果，但它的安全性和有效性还没有在对照试验中得到充分的验证。如果处理不当，这种移植可能会导致新的感染，此外某些关于粪菌移植的广告也存在各种各样的夸大宣传。
　　然而，像对待试验药物那样对粪菌移植进行管理也存在很多困难。粪便菌群的成分极其复杂，评估药物的手段很可能并不适用于它。而且，如果把它看作试验药物，临床上需要治疗的患者也会很难获得使用批准。目前，FDA对粪菌移植的态度实际上是“睁一只眼闭一只眼”：允许医生在常规治疗无效的艰难梭菌感染患者身上自由执行移植，而明确的管理规范至今尚未出台。
　　今年2月，美国食品药品监督管理局（FDA）发布了一个新的粪便移植指南草案。FDA认为，患者或者医生应该明确知晓谁是粪便的捐献者。而这一要求可能对粪便银行不利——他们目前只是将粪便提供者标记为“捐献者1”或者“捐献者2”而已。现在，FDA的草案正在征求反馈意见，这一领域未来将如何走上规范化道路目前仍不得而知。
　　未来的大便药丸
　　以往的粪便移植往往需要插管灌肠，实施过程对患者不够友好。而最近的一项研究进展也使这一问题得到了解决。
　　哈佛医学院和马赛诸塞州综合医院的研究者们使用来自健康捐献者的冷冻粪便做成口服药丸，成功缓解了一些艰难梭菌感染患者的腹泻症状（详情请看：口服“大便”药丸，简单有效治疗肠道感染）。研究者发现，口服大便药丸缓解感染症状的效果十分喜人。但出于目前只是小型的研究，还需要更大规模的研究来证实本次研究的结论，并需要对这种药物的安全性进行进一步的评估。如果“大便药丸”和“粪便库”得以普及，将来就会有更多患者可以从中获益。
　　题图：OpenBiome为纪念治疗1000位患者而制作的T恤图案。图片来自：boston.com
　　参考资料：
　　Boston.com：A Poop Bank in Massachusetts Will Pay You $40 Every Day
　　http://www.openbiome.org/
　　FDA：Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies.

转自：http://www.bewell.org.cn/portal.php?mod=view&aid=3225

A Poop Bank in Massachusetts Will Pay You $40 Every Day

Are you under 50 years old, willing to make daily trips to Medford, and have regular bowel movements? You, my friend, could be earning $40 a day—just for pooping.

All you have to do is visit OpenBiome, launched in 2012 as the only independent nonprofit stool bank in the country. The brainchild of MIT postdoctoral associate Mark Smith, OpenBiome collects, tests, and provides fecal samples to 122 hospitals in 33 states for one of the most interesting medical treatment innovations today: fecal microbiota transplantation.

Mark Smith packages the samples for shipment on dry ice with a colleague Laura Burns.

Carolyn Edelstein / OpenBiome

“Think of us as a blood bank, but for poop,” said Smith, who developed OpenBiome when he saw the gap in the medical structure to provide many patients with the life-saving fecal samples. “You shouldn’t have to fly across the country to get poop.”

Smith works with a team of full-time and part-time researchers, graduate students, gastroenterologists, and business minds to ensure that fecal samples are in every city and town and within a two-hour radius for every person who needs them. Smith said that they’ve hit the four-hour radius so far.

Wait, who wants someone else’s poop?

To keep your digestive and immune systems functioning properly, your body needs to maintain a natural balance of bacteria in your gut. But antibiotics taken to treat infections kill both “good” and “bad” bacteria indiscriminately. They kill it all, upsetting the balance and making the gastrointestinal tract susceptible to C. difficile, a “bad” bacteria. The resulting infection, according to the Centers for Disease Control and Prevention, affects more than 500,000 Americans per year, causing fever, nausea, abdominal pain, and serious diarrhea—and kills 14,000 Americans per year, especially in hospitals and long-term care facilities.

There are antibiotics that treat C. difficile, but as many as 20 percent of the infections return.

Our poop, it turns out, is a plentiful source of this good bacteria, and how do you get one person’s good-bacteria-filled poop into an ailing person? A fecal transplant.

“From the cost perspective, it’s a really efficient treatment for patients who aren’t responding to antibiotics,” said Smith. Including the donor screening costs, research has shown that fecal transplants save on average $17,000 per patient compared to treatment with antibiotics.

Here’s what a sample of fecal microbiota looks like .

Carolyn Edelstein / OpenBiome

While large hospitals and health systems have their own stool banks, many independent physicians and hospitals often do not. This is where OpenBiome comes in, selling them poop at $250 per sample. That’s one price point for a 250mL sample of fecal microbiota prepared for a lower transplant delivery (yep, that low) or a 30mL sample for an upper transplant delivery (through your nose).

While health insurance companies cover some of the cost, Smith said the price tag is key to paying for the processing and distribution of the samples, finding and screening the donors, while still keeping it affordable for patients paying out of pocket.

“The real challenges is that right now it’s still categorized as an explorational drug by the FDA. Until that changes it’s really not going to find universal adoption because there’s still challenges with how insurance companies reimburse it,” said Smith.

Unfortunately, the fecal transplantation process tends to be very uncomfortable and invasive. Physicians traditionally transplant the stool samples through a colonoscopy, enema, or a nasogastric tube that runs from the nose into the digestive tract.

Soon, however, poop may come in the form of a pill. The latest research by doctors at Massachusetts General Hospital, and published in JAMA Internal Medicine in October 2014 has shown frozen capsules of fecal material to be 90 percent effective in treating the C.diff infections. OpenBiome has collaborated with many hospitals across the country in developing and manufacturing these capsule-size samples for treatment.

How many lives could you change with your poop? Here's our handy guide.#EatMoreFiber #FecalTransplants pic.twitter.com/DOlyvfEMKx

— OpenBiome (@OpenBiome) August 13, 2014

Where do I sign up to donate?

To become a paid donor to OpenBiome, you have to undergo thorough screenings, from a 120-question health history with a physician to a travel history analysis and, of course, recent use of antibiotics. Once a donor’s sample dump is reviewed by the lab for any infectious agents and the health of the bacteria, the donor’s blood is tested for standard blood borne diseases as well as hepatitis A, B, C, syphilis, and HIV/AIDS. All of these screening costs (which total more than $1,000 per donor) are covered by OpenBiome, so the markup on the poop donations seems pretty reasonable.

Vladimir Pootin icon, a nickname for one of OpenBiome’s anonymous donors.

Carolyn Edelstein / OpenBiome

OpenBiome targets younger adults, since they tend to be a lot healthier, with the average donor’s age ranging from late 20s to early 30s. The company has also focused its recruitment efforts on nearby Tufts University’s student population.

Once a donor’s sample passes the medical exam, he or she is enrolled and scheduled to visit the Medford facility every day. Each visit takes 30 minutes, during which the donor produces a sample into a hat-shaped bowl that rests over an ordinary toilet. Then the donor walks out with $40.

The cold, hard cash is not, however, the only reward. To further encourage new donors to sign up, and current donors to donate more often, OpenBiome is turning pooping into a game, awarding Super Pooper nicknames—such as Vladimir Pootin, King of Poop, and Winnie the Poo—to those donors with the most samples. (These heroes remain anonymous.) The more doo you donate, the higher your Super Pooper character will climbs in the rankings. So eat your fiber!

“These donors may seem very mild-mannered and think going to the bathroom is a humble thing,” said Smith, “but each sample they bring in can treat four or five patients.”

Pooperoni? Baby-Poop Bacteria Help Make Healthy Sausages

这份香肠的秘方来自婴儿粑粑，你要尝尝看吗？

作者之一 Jofré的两篇文献：

http://www.ncbi.nlm.nih.gov/pubmed/24290655

http://www.ncbi.nlm.nih.gov/pubmed/24211552