彼之良药乃吾之粪便也

Mark Smith was a microbiology graduate student at the Massachusetts Instituteof Technology when, in 2011, a family friend became infected with the notorioussuperbug clostridium difficile. C. diff can cause severe diarrhea, disability,and malnutrition and is responsible for roughly 14,000 deaths in the UnitedStates each year. In 2012, after taking seven rounds of the antibioticvancomycin and failing to improve, Smith's friend received a DIY fecaltransplant from his roommate—in their apartment, using an over-the-counterenema kit. The friend recovered within days, but "the whole thing was absurd,not at all how it should be done," Smith said.

Fecal transplantation—transferring the feces of a healthy person into the bowelof someone with an infection—appears in published case reports as early as1958. But in the past few years, scientists have established with more rigorthat it can resolve recurrent C. diff infections around 90 percent of the time.In 2013, a randomized controlled trial published in the New England Journal ofMedicine showed that the procedure worked better for this condition thanantibiotics—so much better that researchers stopped the study early, saying itwas unethical to continue to deny the transplants to the control group.

粪便移植 – 从健康人体内取出粪便，注入被感染者的肠道内 – 早在1958年就有过公开报道。但最近几年，科学家确信通过粪便移植能解决90%艰难梭菌造成的传染病。2013年，新英格兰医学杂志上发表的随机控制实验显示，对于艰难梭菌感染，粪便移植是比抗生素更有效的治疗方式。研究者们甚至提前停止了相关实验，表示不向控制组移植粪便是不道德的。

Yet access to fecal transplants has proven challenging. As recently as 2013,Amy Barto, a gastroenterologist at the Lahey Clinic in Massachusetts, said herpatients had to find their own stool donors, whom the clinic would screenindividually. On the day of the procedure, the donor had to provide a freshstool sample, which Barto said she personally mixed using a blender from Targetand transplanted into the patient's colon. "It was embarrassing and stressfulfor patients to find their own donors, and expensive to have them screened,"she said. "I did about 100 procedures with the blender, and it was notefficient."

然而目前粪便移植仍是一项挑战。2013年，艾米﹒巴托是马萨诸塞州莱希诊所的一名胃肠科医师。她说她的病人不得不自找粪源，由诊所对其进行单独筛选。在移植当天，捐粪者需要提供一份新鲜的大便样本，由巴托医生亲自混合病人的粪便，然后注入病人的结肠中。她说："对病人来说，找捐粪者是一项尴尬和充满压力的任务，筛选的费用也很昂贵。我大概做过100多次混合粪便移植，但是效果并不明显。"

In 2013, Smith and a college friend, James Burgess, decided to start a not-for-profitstool bank, called OpenBiome, providing pre-screened, frozen samples to doctorsand hospitals. Smith's MIT advisor, Eric Alm, offered guidance as well as acorner of his laboratory, and the team began to recruit donors, mainly amongMIT and Harvard researchers. "When OpenBiome was established, my quality oflife went through the roof," Barto said. More importantly, access to theprocedure "just blossomed." More doctors were willing to get involved andpatients were able to able to get the procedure more quickly, with fewerbarriers and less expense.

2013年，史密斯和大学朋友詹姆斯﹒博格斯决定设立一家非盈利性质的大便银行 - 开放生物圈，向医生和医院提供经过事先筛选的冷冻粪便样本。史密斯在麻省理工的导师埃里克﹒阿尔穆提供建议指导和一部分的实验室空间。项目团队开始征集捐粪者，主要对象是麻省理工和哈佛的研究者们。巴托医生表示："当开放生物圈成立的时候，我得到的样本质量急速上升，"更重要的是，开放生物圈获得的样本数量有了"爆发性的增长。"更多的医生开始愿意参与进来，病人能够更快捷、更不受阻碍、以更加经济的方式获得粪便移植。

One such patient was Natalie Jamil. In April, Jamil, then 25, discovered that aroot canal she had had for years was badly infected. Her dentist extracted thetooth, treating her with antibiotics before and after the procedure. A weekafter she stopped taking the drug, however, she began to vomit and developedsevere diarrhea, cramping, and pain in her joints. Jamil had recently taken ajob as a secretary in Washington D.C., but "it became impossible to get towork, and I was asked to resign," she said. "I was left with no job, no healthinsurance, and no tooth."

娜塔莉﹒贾米尔就是这样一位病人。4月时，25岁的贾米尔发现她常年患病的牙根管感染严重。她的牙医拔掉了牙齿，在手术前后使用了抗生素。停药一周后，她开始呕吐并发展出严重腹泻、痉挛和关节疼痛的症状。贾米尔此时在华盛顿特区获得了一份秘书工作，她说："我病得几乎没法去工作，被要求辞职。于是我丢了工作、没有健保还拔掉了牙齿。"

Searching the web in desperation, she found Edmond. "I had lost over 25 poundsin two months," Jamil said. "I was ready to do anything."

绝望中，贾米尔开始上网搜索。她找到了埃德蒙："我在两个月内体重减轻了25磅，我想我已经准备好面对一切。"

In June, Jamil received the treatment using frozen stool from OpenBiome. Edmondadministered the sample through a tube that threaded in through her nose anddown into her small intestine. "It was like the flicker of a light," she said."The next day I was back on my feet. My stomach was calm. I wasn't havingdiarrhea. It was like magic."

6月，贾米尔从开放生物圈获得了冷冻大便样本，开始接受治疗。埃德蒙往贾米尔的鼻子里插入一根软管直通小肠。他就是通过这根软管对大便样本进行操作。贾米尔说："这就像一道闪光，第二天我就开始好转了。我的胃不疼，也不拉肚子了。这真是太神奇了。"

OpenBiome is similar in some ways to a blood bank, which also collects,screens, and distributes biological material. Early on, though, it became clearthat the group faced different challenges in recruiting donors and testingsamples. For one thing, few applicants qualified: Anyone who had had agastrointestinal disease, recently used antibiotics, or traveled to any countrywith a risk of waterborne illness was rejected, even before their stool wasanalyzed for pathogens. It was sometimes awkward turning away MIT colleagueswho wanted to contribute stool, Smith said, but "it helped to say, ‘Hey, I'mnot eligible either.'"(Smith's brother lives in Singapore and he visits thereeach year.) OpenBiome tests stool for an extensive list of pathogens, includingHIV, hepatitis, and syphilis, which can be transmitted through bodily fluid.But they also screen for disorders, from obesity to metabolic syndrome toautoimmune diseases, that are not traditionally viewed as contagious but havebeen at least correlated with disturbances in gut bacteria. At a blood bank, noone worries that transfusions might make patients obese.

开放生物圈某种程度上类似于血液银行，对生物材料进行收集、筛选和分配。起初，显然在招募捐粪者和样本测试等方面，研究小组面临多重挑战。一方面来说，合格的捐赠者很少：在做大便病原分析前，任何患有肠胃疾病、最近使用过抗生素或去过可能感染水传疾病国家的人都不能捐献。史密斯表示：拒绝那些想提供大便样本的同事有时候是很尴尬的，但"告诉他们‘我也不合格。'能有效缓和尴尬的气氛。"（史密斯的兄弟住在新加坡，他每年都去拜访。）开放生物圈对粪便样本进行各种病原分析，包括通过体液传播的艾滋病毒和肝炎等。他们还对肠胃紊乱、肥胖、新陈代谢综合征、自身免疫性疾病进行筛选。原先这些疾病并未被视为具有传染性，但至少会对肠道菌群产生影响。而在血液银行，没人担心输血会造成肥胖。

OpenBiome fecal microbiota preparationsin storage (Carolyn Edelstein)

开放生物圈储备的粪便微生物备品（卡洛琳﹒埃德尔斯坦）

Rather than casting its net wide for donors, OpenBiome cultivates a small groupof stalwart contributors. That way, the cost of testing, which can be roughly$1500 per donor, is spread over many patients and treatments. Contributors inthis model make a major commitment. They are required to bring in sampleswithin an hour of passage, since the bacterial composition of stool changesrapidly with exposure to air. "We have one guy who brings his samples in on[Boston's T train]," Smith said. But for the most part, donors are students wholive or work close by. When the project moved from Alm's lab at MIT, thisspring, to a new location near Tufts University, OpenBiome sought out a newcohort of dedicated graduate students. Their constancy also means the group canreassure doctors that the individual whose stool they are receiving has alreadycured numerous cases of recurrent C. diff—and has not caused new infections inany recipients.

比起遍地撒网的方式，开放生物圈更喜欢培养一小批固定的捐粪者。通过这种方式，测试的成本可以压缩至约1500美元一人，惠及许多病人，适用于多种治疗方法。固定的捐粪者为粪便移植做出了重要的贡献。因为暴露在空气中的大便菌群变化极快，捐粪者被要求在一小时内把‘新鲜出炉'的样本送至实验室。史密斯说："我们有一个伙计不得不在波士顿地铁里拉屎取样，"但大部分的固定捐粪者是在麻省理工附近居住或工作的学生。今年春天，开放生物圈项目从麻省理工的阿穆尔实验室移至塔夫茨大学时，开放生物圈筛选出了一批新的固定捐粪者，他们都是塔夫茨大学的研究生。这批捐赠者坚持不懈的努力使研究小组能确保大便样本的质量，向医生保证他们获得的样本已经治愈了无数复发性艰难梭菌病例 – 而病人也没有感染新的疾病。

"Their standards are incredibly high, and the testing they do is much betterthan what's done in individual doctors' offices," said Edmond, who recentlyjoined OpenBiome's clinical advisory board. OpenBiome quarantines donors'samples and retests them for pathogens after 60 days, since new infections,like HIV, can take time to show up on immunological tests. In addition,OpenBiome archives a portion of every sample, in case questions emerge down theroad. "If I have a patient 10 years from now" with a virus that's unknowntoday, "I can go back and see if it can be traced" to a stool transplant,Edmond said. "We couldn't possibly have done that before."

埃德蒙最近加入了开放生物圈的临床咨询委员会，他表示："捐赠标准非常严格，筛选测试也比医生办公室里做的强，"。开放生物圈把收到的样本冷冻隔离，在60天后重新测试。因为一些新的传染疾病，如艾滋病毒需要一段时间才能在免疫测试中发现。除此之外，开放生物圈对每份样本进行存档，以免样本在过程中出现问题。埃德蒙说："如果我在十年前为一位病人做过粪便移植"，现在发现他感染了一种未知病毒，"那我（通过粪便存档）可以追溯这种病毒，我们过去就办不到这样。"

To date, OpenBiome has provided more than 930 samples to doctors and hospitalsaround the world. "There is nothing else like them in the country or anywhereelse, as far as I know," Rob Knight, a microbiome expert at the University ofColorado, Boulder told me. Not only are they making the procedure moreaccessible, they also have the potential to collect large-scale data onoutcomes. And they can support research by providing standardized,well-characterized samples to scientists.

开放生物圈至今已经向全世界的医生和医院提供了930多份大便样本。科罗拉多大学的微生物专家罗伯﹒奈特告诉我："据我所知，开放生物圈在美国和全世界都是仅此一例，"他们不仅为粪便移植提供便利，还可以从成果中收集大量信息，向科学家提供标准化和特性化的样本支持研究。

"That is an absolutely critical piece of the puzzle," Knight said, since, forall the enthusiasm, researchers have yet to understand how, exactly, thetreatment works. Like Jamil, most patients have undergone antibiotic therapyrecently for another condition. Those antibiotics "start killing off goodbacteria, then C. diff takes over and produces a toxin that causes the diarrhea,"Edmond said. Fecal transplantation reestablishes a healthier community of bugsthat seems to drive out the C. diff or hold it in check. The approach is bothholistic and rudimentary.

奈特说："这绝对是解开粪便移植有效性的关键步骤"。和贾米尔一样，大部分需要粪便移植的病人之前都使用过抗生素治疗其他疾病。这些抗生素"开始杀死好的细菌，于是艰难梭菌开始控制和生产造成腹泻的毒素"。粪便移植为病人重新创造出一个健康的细菌环境，似乎能驱逐或抑制艰难梭菌。这种方法既简单又全面。

"It's a crude tool we're using to repair the damage done by another crude tool,which is antibiotics," Alm said. Part of OpenBiome's goal is to understand whatusually enables fecal transplants to succeed—and what sometimes causes them tofail. In particular, the group is asking whether certain combinations of bugs,or certain genetic relationships between donor and recipient, are integral tothe cure.

阿尔穆说道："我们用一种原始的方法来弥补另一种原始疗法 – 抗生素所造成的伤害"。开放生物圈的目标之一是解开粪便移植成功的秘诀 – 以及失败的原因。研究小组提出更具体的问题：治愈的关键是某些细菌的组合，还是捐粪者与受捐人之间的遗传资源关系？

Research on the trillions of bacteria that live on and in our bodies isflourishing. Our skin, mouths, colons, lungs, and many other sites play host tothese bugs, which in turn contribute to our health. These findings havesupported a view of the body as an ecosystem, in which human and bacterialcells continually interact. Various diseases, from inflammatory bowel diseaseto type 2 diabetes, have been linked to reduced diversity in the ecosystem orother anomalies in the balance of bugs. There has been a wealth of association,a fascination with pattern-finding, and an exuberance toward new data notunusual for a fast-emerging field.

针对数万亿生存在人类体表和体内细菌的研究正蓬勃发展。我们的皮肤、嘴、结肠、肺和其他器官是这些细菌的容身之处，作为回报，细菌会维持我们身体的健康。这些研究成果支持的观点是将身体视为一个生态系统。在这个系统中，人类和细菌细胞频繁互动。多种疾病，从肠道炎症到II型糖尿病，都与生态系统中细菌种类减少或菌种平衡的异常现象有关。对于这一快速崛起的研究领域，丰富的想象力、充满魅力的模式搜寻、层出不穷的新数据已经成为一种常态。

以下是来自联合国网友评论：

★"If you can't leave the 

house because you're 

having 20 bowel 

movements a day, do 

you really care if you 

might be at higher risk 

for a chronic disease 10          

years from now?"

"一天拉上二十趟，

家里门都出不了， 十年以后慢性病， 现在谁还管得了？"

★But as the science develops, and researchers hope to harness its insights inservice of patients, it will be critical to establish which conditions are infact caused by microbial disturbances and which are merely correlated withthem. Fecal transplantation could play a valuable role in this regard,demonstrating whether altering the mix of bugs can also cure the disease. Thenearly magical success of the treatment against recurrent C. diff does notnecessarily mean, after all, that it will succeed for other conditions.

但随着科学的不断进步，研究者们希望能把研究分析转化为医疗成果。确定由哪些微生物干扰造成哪种疾病，而哪些微生物仅仅与其相关联这一点非常重要。改变细菌组合是否同样能够治愈疾病？粪便移植为这个问题提供了解决方案。粪便移植奇迹般的治愈艰难杆菌并不意味着对其他疾病它也能成功。

★So far, researchers have published case reports or small studies testing fecaltransplantation for inflammatory bowel disease, irritable bowel syndrome,chronic fatigue syndrome, and multiple sclerosis, among others. But fewrandomized controlled trials have yet been completed. In one study, publishedin 2012, Dutch researchers transplanted stool from lean donors to patients withmetabolic syndrome, a condition that is characterized by insulin resistance andis often a precursor to diabetes. They found that the recipients' insulinsensitivity improved, meaning that they were better able to process sugar. Inanother study, presented at a conference this summer, scientists from McMasterUniversity in Canada studied fecal transplantation in patients with ulcerativecolitis, a type of inflammatory bowel disease. They did not, however, find astatistically significant effect. "The result was disappointingly negative,"Richard Hunt, a gastroenterologist and emeritus professor at McMaster, said inan email. It may be that the dose of the stool, the duration of treatment, orthe patients' clinical characteristics will turn out to matter more for treatingIBD than for C. diff. Even so, "there have been a number of trials now in IBDwhich have been negative and we probably need to think again before investingmore time and money."

迄今为止，研究者们已经为肠道炎症、肠道易激综合征、慢性疲劳综合症和多发性硬化症的粪便移植建立了案例报告和小规模的研究测试，但随机性对照测试没有完成的案例。发表于2012年的一份研究论文中，荷兰研究者将体型较瘦的捐献者粪便注入代谢综合症患者的体内（代谢综合症与胰岛素抵抗有关，通常会导致糖尿病）。研究者发现，患者的胰岛素敏感度有所好转，这意味着患者能更好的处理糖份。本年度夏季大会公布的另一项研究中，加拿大麦克马斯特大学的科学家对溃疡性结肠炎病人的粪便移植治疗进行了研究。溃疡性结肠炎是一种肠道炎症，他们发现粪便移植对于这种疾病没有明显的效果。理查德﹒亨特是麦克马斯特大学的胃肠病学家和名誉教授，他在一份电子邮件中表示"研究结果令人失望"。也许对于治疗肠道炎症而言，移植粪便的剂量、治疗持续时间或病人的临床特征更为重要。即便如此，"一系列的肠道炎症测试表明，粪便移植效果不佳。也许在花费更多时间和金钱之前，我们应该再斟酌斟酌。"

★For C. diff, adverse events associated with fecal transplantation are rare:Some patients report mild bloating, abdominal pain, or constipation. (If thestool is administered by colonoscopy, the risks of that procedure also apply.)But it's possible that negative outcomes may be underreported, since nonational registry of patients yet exists. (No one even knows how many fecaltransplants are performed in the U.S. each year, Smith said.) As the largestsingle provider of fecal matter, OpenBiome might therefore help to verify itssafety—or reveal any longer-term risks, like obesity or diabetes. "It'simportant for patients to be able to make informed decisions," Smith said, evenif desperation may drive them to get the treatment anyway. Edmond, too, issensitive to the importance of further research, but as he puts it: "If you're80 years old and can't leave the house because you're having 20 bowel movementsa day, do you really care if you might be at higher risk for a chronic disease10 years from now?"

对于艰难梭菌，粪便移植的不良事件比较罕见：一些病人报告有轻微的腹胀、腹痛或便秘现象。（通过结肠镜检查操作的粪便，同样会产生此种风险。）但也有可能是不良反应没有报告，因为全国范围的病患注册系统还没有建立。（史密斯说，美国每年实施粪便移植的病患到底有多少没人知道。）作为全国最大的独立粪便供应者，开放生物圈将帮助核实粪便的安全性– 或揭示任何长期风险，如肥胖或糖尿病等。即便病人是出于绝望才进行粪便移植的，史密斯表示："对病人来说，获得必要的信息再做决定是非常重要的"。埃德蒙也十分赞同对于粪便移植的风险性做进一步研究。但他同样表示："如果你已经80岁了，因为一天拉上20趟而离不开家门半步，那你真的介意十年以后得慢性病的几率变高吗？"

★The Food and Drug Administration, however, is clearly concerned about potentialrisks. In 2013, the agency indicated that it regarded stool for the procedureas an investigational new drug. That meant that hospitals or physicians couldonly offer it to patients if they submitted an investigational new drug, orIND, application, with all of the attendant scientific and bureaucraticrequirements. The backlash was swift. Doctors and patients worried that redtape would limit access to a lifesaving therapy and drive more people toperform the procedure on their own, with fewer safeguards. "I have at leastthree more patients in the process of preparing for self-administered fecaltransplant at home," Edmond wrote in May 2013.  "These patients arehighly motivated, know the data on effectiveness and won't be told no!"

然而，美国食品和药物管理局非常关注粪便移植的潜在风险。2013年，管理局表示应将移植的粪便视为试验性新药。这意味着医院或医生只能在向管理局呈递试验性新药或IND申请，满足所有相关的科学和行政要求后才能向病人提供移植的粪便。这一观点很快引起了强烈的反响。医生和病人担心管理局的繁文缛节会妨碍病人获得救命的治疗，或驱使更多的人在没有安全保障的情况下私自进行粪便移植。2013年5月，埃德蒙写道："我至少有三位病人准备自己在家进行粪便移植。这些病人积极性很高，了解有效数据而且坚持要这么做！"

★In June 2013, the FDA relented. It announced that it would not enforce itsrule, temporarily at least, as it studied the matter further. Doctors couldoffer fecal transplants for recurrent C. diff, as long as patients gave theirinformed consent. The issue remained unresolved, however, and in February 2014,the FDA offered an updated draft guideline that once again set advocates onedge: The agency proposed that its previous enforcement discretion would becontingent, in part, on either the doctor or the patient knowing the donorpersonally. So "if I test a donor once for infections and that donor is knownto the patient, I don't need an IND," Edmond wrote at the time. "But if Iobtain the stool from a stool bank that has a small number of highly selecteddonors that are tested serially every 60 days … I need an IND?" Such arequirement, if implemented, would undermine large-scale stool banking likethat done by OpenBiome, its founders said.

2013年6月，食品和药物管理局妥协了。管理局宣布不会实施这一规定，至少在进一步研究之前不会实施。只要病人签署了知情书，医生就可以向艰难梭菌病人提供粪便移植治疗。但问题并没有得到解决，2014年2月，管理局发布了一份更新过的指导方针草稿。又一次将争端推上了风尖浪口：管理局表示之前针对粪便移植的自由衡量权仅仅在某些条件下成立，换句话说，医生或病人必须与捐粪者认识。所以"如果我曾经为一位捐粪者做过感染测试，而病人又认识这位捐献者，那我就不需要进行IND申请，"埃德蒙写道，"但如果我获得的大便样本来自粪便银行精挑细选的捐粪者，每60天仔细检测一番…那我还必须进行IND申请？"开放生物圈的创立者表示：如果实施这种要求，很大程度上将会破坏开放生物圈的工作。

★Ironically, this requirement might also increase the risks associated withfecal transplants. The risk of blood transfusions is known to be higher whenrecipients choose donors, rather than when they receive bloodanonymously—perhaps because friends or family members feel pressured to donateeven if they have engaged in risky behavior. "There is no reason to think itwould be different here," Edmond has written. (The FDA said that it isconsidering this point, among others, and that "the draft guidance document hasnot been finalized or issued for implementation.")

讽刺的是，这个要求还可能会提高粪便移植的风险。众所周知，当输血者指定捐血者时，输血的风险会比接受匿名捐献者的更高 – 可能是因为即使捐血者曾经参与过高危行为，但作为朋友或家人，他们仍旧会产生必须捐血的紧迫感。埃德蒙写道："没有理由认为（粪便移植的）情况有所不同，"（食品和药物管理局表示他们正在考虑这个问题，"指导文件草稿仍未定稿或发布以供实施。"）

★The agency's regulation of potentially infectious material is fraught withlegal and historical peculiarities. For instance, the FDA does not regulatedonated breast milk, although it warns on its website that milk can transmitinfectious diseases, like HIV, and should be screened. Nor does it requiremanufacturers of dietary supplements, which can include probiotics containinglive bacteria, to seek the agency's approval. (The FDA's Center for BiologicsEvaluation and Research does have jurisdiction, however, over probiotics that areintended to prevent, treat, or cure disease.)

食品和药物管理局针对具有潜在感染性物质的条例充斥着法律和历史怪癖。举例来说，管理局对捐献的母乳或膳食补充剂未作规定，而这两种物品都含有益生菌这种活性细菌，照道理是必须获得管理局批准的。（食品和药物管理局生物制品和评价中心对预防、治疗或治愈疾病的益生菌具有管辖权。）

★In theory, fecal matter could be regulated as a human tissue, like lungs orlivers used for transplantation. Smith, Alm, and a gastroenterologist namedColleen Kelly made the case for this approach in February in an article inNature, noting that the "human gut microbiome has been described as a ‘virtualorgan.'" And several experts agreed: "Of all the categories the FDA has forregulation, tissue is the one that makes the most sense," said Rob Knight of theUniversity of Colorado, Boulder.  "Someone's body made that liver,"he added, and the same could be said of stool for transplant. Formally, though,the category of "human cells, tissues, or cellular or tissue-based products,"as the FDA defines it, excludes "secreted or extracted human products." (Thismeans that milk is excluded, though for some reason semen is not.) It'spossible that a senior official within the executive branch could redefinestool as a tissue, but "we're really uncertain how these decisions are made,"James Burgess of OpenBiome said. The FDA said it "cannot make predictionsregarding the future regulation" of therapies using fecal transplantation.

理论上，粪便类物质可以作为人体组织，如肺或肝移植进行管理。2月份时，史密斯、阿尔穆和一位名叫柯琳﹒凯利的胃肠病学家在《自然》上发表的一篇文章中提出了这个观点。文章中写道："人类肠道中的微生物群被描述为‘重要的器官'之一。"这篇文章获得了几位专家的认同：科罗拉多大学的罗伯﹒奈特表示："美国食品和药物管理局所规范的所有类目中，人体组织（对于移植的粪便来说）是最符合常理的类目。一些人的身体制造了肝脏，我们也可以对移植用的粪便这么说：一些人的身体制造了粪便。"尽管根据更正规的说法，管理局定义的"人类细胞、组织、或基于细胞或组织的产物"类目中并不包括"人类分泌或排放的产物。"（这意味着母乳被排除在外，而精液则因为某些原因列于此类目下。）一位执行办公室的高级官员当然有权决定将粪便列为人体组织，但"我们真的不确定这些决定是如何达成的。"开放生物圈的詹姆斯﹒博格斯这样说道。管理局表示其无法对粪便移植治疗法这种未定规范进行预测。

★Someday, a commercial product may replace stool, making some of these issuesless fraught. "Initially our whole plan was that this would be a bridge,"Burgess said. "We thought it was crazy [that] people weren't getting treated."Work conducted with material from OpenBiome might also aid efforts to figureout the "active ingredients" for treating C. diff, thus guiding efforts tocreate a synthetic substitute. That is a "huge research priority for us," Almsaid. If such a product became available, it's even possible that OpenBiomewould alter its mission to focus more heavily on research.

也许将来的某一天，一种商业产品能取代大便，减轻人们的烦恼。博格斯说："一开始我们的整个计划（开放生物圈）是成为一种纽带，我们认为人们无法得到治疗是疯狂的。"针对开放生物圈物质所做的工作能帮助找出哪种"活性成份"才是治疗艰难梭菌的关键，从而进一步创造出合成药。阿尔穆说："这是我们研究的一大重点"。如果能创造出这种产品，开放生物圈就可能改变其任务，更专注于研究工作。

★In the meantime, though, the group is making nice with the FDA. It is workingto broker a compromise regarding the agency's investigational new drugrequirements. OpenBiome has agreed to help four of its providers perform fecaltransplants as part of an IND study. This multicenter, phase-two trial willtrack up to 200 patients with recurrent C. diff for a year after they receivethe procedure. Regulators are "rightly concerned" about unregulatedtransplants, Smith said, but "they see we can help drive rigorous datacollection … They will get more good data working with us than they would haveotherwise."

与此同时，开放生物圈与管理局维持着良好的关系。它正努力对管理局的试验性新药要求做出让步。作为IND研究的一部分，开放式生物圈已经同意帮助四位捐粪者进行移植手术。这个多通道、两阶段的实验将在一年里持续跟踪200多位接受粪便移植手术的艰难梭菌病人情况。政策制定者们正"谨慎的关注"不受控制的粪便移植手术，史密斯说道，但"管理局的人员发现，我们能帮助进行严格的数据收集…他们和我们合作的话，能获得更好的数据。"