Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)
Diet for Prevention of Recurrent C. Difficile Infection
This study aims to evaluate the impact of diet on the gut microbiome in adults with Clostridioides difficile infection (CDI). Eligible participants will be randomized and receive meals plus different types of health counseling. Counseling visits will be by phone or online videoconference (e.g. Zoom). Meals will be provided for two weeks and then participants will be asked to continue similar meals for 6 more weeks.
Participants will provide responses to questionnaires and multiple stool samples over the course of the study. The goal is to understand how different health factors might impact the risk of becoming infected again with C. difficile in the future.
Of note, this study will conceal the intervention details (type of diets) so that the control group does not increase their intake with the particular diet during the study. Participants in the control arm will be unblinded at the end of the study during a debrief with a member of the study team. At that time participants will be informed of diet being tested.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Kira Newman, MD, PhD
- 电话号码：734-615-4628
- 邮箱：kinewman@med.umich.edu
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- 招聘中
- University of Michigan
-
接触：
- Kira Newman, MD, PhD
- 电话号码：734-615-4628
- 邮箱：kinewman@med.umich.edu
-
首席研究员：
- Kira Newman, MD, PhD
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Non-recurrent non-fulminant CDI (laboratory-confirmed C. difficile infection without prior C. difficile infection within 3 months and no shock, hypotension, ileus, or megacolon)
- Currently receiving treatment or with plan to initiate treatment for CDI
- CDI treatment with standard regimen (fidaxomicin 200milligrams (mg) by mouth (PO) twice a day x 10-14 days or vancomycin 125mg PO 4 x a day (QID) x 10-14 days)
- No prior advanced therapy for C. difficile (i.e. prolonged antibiotic therapy, bezlotoxumab, fecal transplant, other microbial therapy)
Exclusion Criteria:
- Chemotherapy, immunotherapy, or transplant within 12 months
- Colon not in continuity (i.e. status post total colectomy or with current ileostomy)
- Medical comorbidities requiring specific fluid, sodium, or protein intake level outside range of prepared diet options
- Baseline diet with > 11grams fiber/1000 kilocalories
- Low sodium diet, vegan diet, gluten-free diet, Kosher diet or any other diet not able to be accommodated by the metabolic kitchen
- Allergies, food preferences, or other restrictions not able to be accommodated by the metabolic (note: lactose intolerance will not impact eligibility)
- Unwilling to stop probiotic supplements during the study period
- Current antibiotic therapy that will continue after CDI treatment has finished
- Hospitalized or in skilled nursing facility at time of CDI treatment conclusion
- Pregnancy or breast-feeding
- Unable to provide a stool sample of appropriate quality for further analysis (i.e. low volume, adulterated, delayed return, etc.)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental Diet plus health counseling
As stated earlier, the diet and intervention details will not be listed for concealment purposes.
|
Participants will receive 2 weeks of prepared meals.
Participants will then be asked to follow a similar diet for 6 weeks.
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其他：Diet (control diet per protocol) plus health counseling
As stated earlier, the diet and intervention details will not be listed for concealment purposes.
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Participant will have two health counseling visits with a member of the study team between weeks 2-8.
Participants will receive 2 weeks of prepared meals.
Participants will then be asked to follow a similar diet for 6 weeks.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing
大体时间：Baseline, 2 weeks (post feeding period)
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Change from baseline to week 2 (post feeding period) in alpha-diversity of fecal microbiome by 16S rRNA sequencing using Shannon index.
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Baseline, 2 weeks (post feeding period)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline to week 8 in microbiome alpha-diversity (Shannon Index via 16S rRNA)
大体时间：baseline to week 8
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Measured by Shannon Index via 16S rRNA.
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baseline to week 8
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Incidence of recurrent CDI
大体时间：baseline to week 8
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Laboratory-confirmed symptomatic infection requiring treatment.
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baseline to week 8
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Change in CDI-related Quality of Life (QOL) baseline to Week 8
大体时间：Baseline to Week 8
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Patient-reported health-related quality of life assessed using the Clostridioides difficile Quality of Life Survey (Cdiff32) total score (range 0-100; higher scores indicate better quality of life).
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Baseline to Week 8
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Tolerability of diet based on the mean percent of meals consumed during the first 2 weeks
大体时间：2 weeks (during the provided meal period)
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This is during the 2-weeks of receiving provided meals.
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2 weeks (during the provided meal period)
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合作者和调查者
调查人员
- 首席研究员：Kira Newman, MD, PhD、University of Michigan
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.