Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- C.difficile decolonization
研究概览
简要总结
This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 99 patients who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo arm. All arms will receive an identical capsule dosing for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.
详细描述
This randomized placebo-controlled dose-finding trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the IBD patient population.
Participants with confirmed IBD diagnosis who are scheduled for an outpatient colonoscopy for any reason at Brigham and Women's Hospital or clinic appointment at the Crohn's and Colitis Center will be eligible for screening. Participants will be screened for C. difficile colonization via colonic wash sampling during colonoscopy or whole stool following a clinic appointment.
Participants may only have inactive or mild IBD based in clinical scores (see inclusion criteria) to be eligible for screening. Risk factors for colonization will be assessed by comparing colonized vs. not colonized patients.
Participants who are found to be colonized will be randomized 1:1:1 to either placebo or one of two dosing groups of xylitol. The dose A treatment arm will receive 7.5 grams daily of xylitol via gel capsule for 4 weeks. The dose B treatment arm will receive 15 grams daily of xylitol via gel capsule for 4 weeks. The placebo arm will receive identical capsule dosing for 4 weeks. Participants will end dosing at week 4, but monitoring will continue through week 52. Both participants and study team will be blinded to treatment arm allocation.
The primary endpoints assessed are decolonization at week 8 as well as safety and tolerability through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI, which will be evaluated at week 8, week 26 and week 52. Disease activity and symptoms will be recorded from informed consent through the week 52 trial visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Male or female ≥ 18 years of age
- •IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)
- •Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4)
- •Presenting for outpatient colonoscopy or clinic appointment for any indication
排除标准
- •Unable to provide consent
- •Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)
- •Unable to complete study procedures
- •Chronic use of antibiotics
- •Inability or unwillingness to swallow capsules
- •Allergy to xylitol
- •Stool positive for Listeria monocytogenes
研究组 & 干预措施
Dose A of Xylitol
Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.
干预措施: Xylitol (Drug)
Dose B of Xylitol
Patients in this are will be receiving 15g/day of Xylitol over a 4 week period.
干预措施: Xylitol (Drug)
Placebo
Patients in this arm will be receiving placebo over a 4 week period.
干预措施: Placebo (Drug)
结局指标
主要结局
C.difficile decolonization
时间窗: 8 weeks
Absence of C. difficile via PCR in week 8 stool sample
safety and tolerability
时间窗: 8 weeks
Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)
次要结局
- biomass of C.difficile(8 weeks)
- C. difficile infection(52 weeks)
- IBD clinical outcomes(52 weeks)
- IBD clinical outcomes(8 weeks)
研究者
Jessica Ravikoff Allegretti
Director, Crohn's and Colitis Center
Brigham and Women's Hospital