A RANDOMIZED, PROSPECTIVE, DOUBLE-BLINDED, PLACEBO-CONTROLLED ( SHAM-CONTROLLED

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究涉及评价Adacolumn血液分离系统重复治疗的潜在受益和安全性的研究。一旦研究医生确定受试者有资格参加研究，将要求他们审查并签署知情同意书。然后，研究医生将通过获得完整的病史、当前药物使用、采集血液、尿液和粪便样本、进行完整的体格检查和软式直肠乙状结肠镜检查来确认合格性。患者将接受5-15分钟的单采试验，以确定是否有良好的静脉通路。然后受试者将随机接受Adacolumn或安慰剂治疗。在Adacolumn臂中，血液将通过Adacolumn。在安慰剂治疗中，血液将通过塑料管绕Adacolumn流动。受试者共接受10次单采治疗：前2周每周2次，然后每周1次，再持续6周。将在第12周评价受试者的缓解，之后将进入随访计划，每4周一次对受试者进行随访，以评估疾病活动性，直至第24周。在整个研究期间，受试者将填写问卷以评估生活质量，并将进行体格检查和实验室检查（血液和尿液）以监测治疗的有效性和安全性。研究期间将进行两次乙状结肠镜检查。入组没有种族或民族限制。但是，以下个体将被排除，因为他们代表弱势人群：18岁以下的患者、孕妇和不同意在整个研究期间使用避孕措施的有生育能力的女性。 入组研究的受试者将通过姓名首字母缩写和5位数的受试者ID编号识别，该编号将与受密码保护的计算机文件中的患者姓名相关联。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study involves research to evaluate the potential benefits and safety of repeated treatment with the Adacolumn Apheresis System. Once the study doctor has determined that a subject is eligible for participation, they will be asked to review and sign a consent form. The study doctor will then confirm eligibility by obtaining a complete medical history, current medication use, collecting blood, urine, and stool samples, conducting complete physical exam and flexible proctosigmoidoscopy. Patients will receive a 5-15 minute trial of the apheresis to establish that there is good venous access. Subjects will then be randomized to receive either Adacolumn or placebo treatment. In the Adacolumn arm the blood will pass through the Adacolumn. In the placebo treatment, blood will go around the Adacolumn through a plastic line. Subjects receive a total of 10 apheresis treatments: 2 times a week for the first 2 weeks and then once a week for 6 more weeks. Subjects will be evaluated for response at week 12 after which they will enter into a follow-up program in which subjects will be followed every 4 weeks to assess disease activity until week 24. Throughout the study subjects will fill out questionnaires to assess quality of life and physical and lab evaluations (blood and urine ) will be done to monitor effectiveness and safety of treatment. A sigmoidoscopy will be performed twice during the study. There will be no racial or ethnic limitations for enrollment. The following individuals will, however, be excluded as they represent vulnerable populations: patients under 18 years, pregnant women, and women of reproductive potential who don t agree to use birth control throughout the study. Subjects enrolled in the study will be identified by initials and 5 digit subject ID numbers which will be linked to the patient s names in a password protected computer file.