“糞便銀行”：救人拿錢兩不誤

如果你年齡小於50歲，排便規律，而且願意每天去美國麻省麥德福德跑一趟，那麼沒準你可以每天得到40美元的外快，而你需要做的事情只是生產便便。
　　要想得到這筆收入，請拜訪“開放生物群”（OpenBiome）。它是全美唯一的獨立非營利性“糞便銀行”，初建於2012年，由麻省理工學院博士後馬克•史密斯（Mark Smith）創立。開放生物群向33個州的122家醫院提供糞便樣本用於腸道菌群移植治療。
　　為什麼要捐糞便？
　　糞便庫收集的這些糞便樣本主要用於治療一種特殊的腸道感染——艱難梭菌感染。這種疾病的主要症狀是腹瀉，它的出現往往與腸道菌群的失調有關。艱難梭菌感染每年可導致1.4萬美國患者死亡。由於抗生素耐藥問題愈發嚴重，這種腸道感染也變得更加難治和容易復發。而對於藥物治療難以奏效的艱難梭菌感染患者而言，移植健康人糞便中的腸道菌群是目前最理想的治療方法。
　　經典的糞菌移植方法是通過口鼻或肛門插管，將新鮮糞便送達腸道。這樣新鮮大便中的腸道細菌就可以在被移植者體內重建腸道菌群，緩解腸道感染。為了保證治療效果，既需要糞便提供者擁有健康的腸道菌群，又需要保證糞便新鮮以維持細菌的活性，而“糞便銀行”就是在這樣的需求下應運而生的。
　　捐獻過程並不容易
　　捐糞便換錢聽起來似乎是極其輕鬆愉快的致富之路，而事實上，想要成為一名糞便有償捐獻者並不是那麼容易。為確保糞便質量合格，捐獻者必須首先填寫由120個問題組成的調查問卷，交代自己的既往病史、旅行經歷以及近期使用抗生素情況。接下來還要進行糞便檢查，確保腸道菌群健康、不含高危病原體。然後，還要抽取血樣，進行甲乙丙型肝炎、梅毒、艾滋病等傳染病檢查。全套篩查下來大約要花上1000美元，所幸“糞便銀行”會承擔全部費用。
　　篩查合格之後，捐獻者就可以正式上崗了。開放生物群希望糞便捐獻者可以在60天內進行頻繁的捐獻，在此期間，捐獻者需要每週至少來機構4次，並把他們的“捐獻樣品”投入坐便器上一個帽子形狀的收集器裡。每成功捐獻一份樣本，捐獻者就可以得到40美元報酬。一次採集的糞便標本通常可以用於4~5位患者的治療。收集到的糞便樣本會在-80℃條件下儲存，並放在乾冰上運輸。開放生物群的工作人員表示，這些冷凍便便的療效與新鮮的一樣好，而且它們更加方便，“保質期”更長（可達6個月），還可以儲存起來以備不時之需。
　　

　　提供50克糞便，即可讓一位患者得到治療。圖片來自：OpenBiome
　　“糞便銀行”的目標人群主要是年輕人，因為他們通常更加健康。這裡的捐贈者平均年齡大約在30歲上下。附近塔夫脫大學的學生們也為糞便庫貢獻良多。為了鼓勵人們捐獻，“開放生物群”在例行報酬以外還設定了“每月捐獻最多獎”、“單次捐獻最多獎”之類的獎項，並向優秀的捐獻者們授予“拉屎之王”（King of Poop）、“小翔維尼”（Winnie the Poo）之類逗趣的稱號。
　　FDA的管理難題
　　“糞便銀行”專案聽起來十分美好，不過在類似醫療服務的監管方面依然存在不少爭議。
　　如何對糞菌移植進行恰當的評估和監管，這是美國食品藥品監督管理局（FDA）面臨的一大難題。FDA指出，雖然在不少案例中，這種治療手段都顯示出了良好的效果，但它的安全性和有效性還沒有在對照試驗中得到充分的驗證。如果處理不當，這種移植可能會導致新的感染，此外某些關於糞菌移植的廣告也存在各種各樣的誇大宣傳。
　　然而，像對待試驗藥物那樣對糞菌移植進行管理也存在很多困難。糞便菌群的成分極其複雜，評估藥物的手段很可能並不適用於它。而且，如果把它看作試驗藥物，臨床上需要治療的患者也會很難獲得使用批准。目前，FDA對糞菌移植的態度實際上是“睜一隻眼閉一隻眼”：允許醫生在常規治療無效的艱難梭菌感染患者身上自由執行移植，而明確的管理規範至今尚未出臺。
　　今年2月，美國食品藥品監督管理局（FDA）釋出了一個新的糞便移植指南草案。FDA認為，患者或者醫生應該明確知曉誰是糞便的捐獻者。而這一要求可能對糞便銀行不利——他們目前只是將糞便提供者標記為“捐獻者1”或者“捐獻者2”而已。現在，FDA的草案正在徵求反饋意見，這一領域未來將如何走上規範化道路目前仍不得而知。
　　未來的大便藥丸
　　以往的糞便移植往往需要插管灌腸，實施過程對患者不夠友好。而最近的一項研究進展也使這一問題得到了解決。
　　哈佛醫學院和馬賽諸塞州綜合醫院的研究者們使用來自健康捐獻者的冷凍糞便做成口服藥丸，成功緩解了一些艱難梭菌感染患者的腹瀉症狀（詳情請看：口服“大便”藥丸，簡單有效治療腸道感染）。研究者發現，口服大便藥丸緩解感染症狀的效果十分喜人。但出於目前只是小型的研究，還需要更大規模的研究來證實本次研究的結論，並需要對這種藥物的安全性進行進一步的評估。如果“大便藥丸”和“糞便庫”得以普及，將來就會有更多患者可以從中獲益。
　　題圖：OpenBiome為紀念治療1000位患者而製作的T恤圖案。圖片來自：boston.com
　　參考資料：
　　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　　FDA：Draft Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile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.

轉自：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.

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.”