Can Low-fat/high-fiber or Fermented Diet Modulate the Gut Microbiome to Improve Surgical Outcomes?
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in gut microbiome alpha and beta diversity according to pre-operative diet intervention
研究概览
简要总结
The aim of the study is to evaluate the gut microbiome (i.e. bacteria, viruses, and fungi that reside in the gut) of people undergoing abdominal surgery, evaluate whether specific diets can change the gut microbiome, and, if so, whether those changes translate into better surgical outcomes.
详细描述
Standard of care: patients undergoing major abdominal colorectal surgery are sometimes advised to eat healthfully prior to surgery, but without more specific recommendations regarding their diet.
Research Activities:
- Screening: eligible patients will be identified through screening the clinic schedules.
- Enrollment: in person or remotely, after the patient is determined to require major abdominal surgery, they will be invited to participate in the study. If they consent to participate, they will be randomized to receive either low-fat/high-fiber diet, high-fermented diet, or continue with their normal diet for 10-14 days prior to the surgery.
- Intervention: at baseline, data will be collected regarding clinical information of the patients (age, body mass index, comorbidities, medications or supplements, physical activity levels, antibiotic or probiotic use in the past six months), and baseline dietary pattern, which will be evaluated through application of a validated Food Frequency Questionnaire (DHQ III). Patients in the intervention arms (low- fat/high-fiber diet or high-fermented diet) will receive meal samples during the 10-14 days preceding surgery. Patients in the control arm will receive a $25 grocery voucher. Adherence to the diet will be assessed through regular check ins with the patients.
Stool samples will be collected in five timepoints: at the beginning of the study, after the dietary intervention, during surgery, in the first week after the surgery, and between 21-30 days after surgery. The stool samples will be sent for analysis of the microbiome.
A fragment of the resected bowel will also be sent for analysis of the mucosal-associated microbiome. 4. Closeout: After surgery, all patients will receive the same standard dietary protocol and care, and will be followed for 30 days without any further intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, 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
- •undergoing major abdominal colorectal surgery with intestinal resection in 2 or more weeks
排除标准
- •patients who do not speak English or Spanish
- •houseless patients
- •decisionally impaired patients
- •presence of ileostomy prior to the surgical procedure
- •surgery without intestinal resection
研究组 & 干预措施
Control Arm
Standard care - patients will not receive specific dietary advice.
High Fiber/low fat
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
干预措施: high-fiber/low fat (Behavioral)
Fermented
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
干预措施: fermented (Behavioral)
结局指标
主要结局
Change in gut microbiome alpha and beta diversity according to pre-operative diet intervention
时间窗: Two weeks prior to surgery
Metagenomic sequencing will be performed on stool samples before and after dietary change.
次要结局
- Frequency and severity of surgical complications according to pre-operative diet(30 days after surgery)
- Change in gut microbiome alpha and beta diversity after surgery according to pre-operative diet(Surgery date until 1 month after surgery)
研究者
Cindy Kin
Assistant Professor of Surgery
Stanford University
