An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate safety of IMT in patients undergoing colon surgery
研究概览
简要总结
This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able/willing to provide informed consent
- •Between 18-75 years of age
- •Undergoing surgery for a history of diverticulitis or sigmoid colon cancer.
- •Able to provide fecal samples
- •Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence
排除标准
- •Any history of inflammatory bowel disease
- •Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child- bearing potential on the proposed day of IMT (prior to the receipt of IMT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive IMT treatment.
- •Life expectancy of < 6 months
- •Presence of ileostomy or colostomy
- •Known history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
- •Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)
- •Patients with neutropenia (an absolute neutrophil count < 0.5 x 109 cells/L) obtained on a complete blood count with differential at screening.
- •History of solid organ or bone marrow transplant.
- •Anticipated recurrent antibiotic use (e.g., patients with frequent urinary tract infections or sinusitis).
- •History of severe anaphylactic food allergy.
- •History of celiac disease.
- •Patients receiving cancer chemotherapy, immunotherapy, or radiation.
研究组 & 干预措施
IMT group
individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT solution
干预措施: IMT (Drug)
结局指标
主要结局
Evaluate safety of IMT in patients undergoing colon surgery
时间窗: Day of surgery, post-op Day 1-14, Day30, Day60, Day90, Day120, Day150, Day180
Collected via adverse event monitoring, to be reported as frequency, relatedness, expectedness, and severity of AEs/SAEs
compare fecal microbiota prior to and after IMT
时间窗: Day -60-0, Day of surgery, post-op Day1-3, Day14, Day30, Day90, Day180
Collected via stool sample collection, to be reported as sequenced microbial DNA profiles (alpha diversity, beta diversity)
次要结局
- Evaluate engraftment of donor microbiota(Day -60-0, day of surgery, postoperative Day1-3, Day14)
- Evaluate changes in circulating markers of inflammation: WBC(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Evaluate changes in circulating markers of inflammation: Hemoglobin(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Evaluate changes in circulating markers of inflammation: Platelets(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Evaluate changes in circulating markers of inflammation: Electrolytes(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Evaluate changes in circulating markers of inflammation(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Evaluate changes in circulating markers of inflammation: alkaline phosphatase(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Evaluate changes in circulating markers: Albumin(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Evaluate changes in microbial metabolites: Fecal IgA(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)
- Compare baseline microbiome characteristics with changes over time after IMT(Day -60-0, day of surgery, postoperative Day1-3, Day14, Day30, Day90, Day180)