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临床试验/NCT05027763
NCT05027763Unknown不适用

Can Low-fat/high-fiber or Fermented Diet Modulate the Gut Microbiome to Improve Surgical Outcomes?

Stanford University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

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:

  1. Screening: eligible patients will be identified through screening the clinic schedules.
  2. 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.
  3. 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

No Intervention

Standard care - patients will not receive specific dietary advice.

High Fiber/low fat

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cindy Kin

Assistant Professor of Surgery

Stanford University

研究点 (1)

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