Effect of Preoperative Diet on Perioperative Gut Microbiome
Primary Purpose
Surgical Site Infection
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high-fiber/low fat
fermented
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria:
- undergoing major abdominal colorectal surgery with intestinal resection in 2 or more weeks
Exclusion Criteria:
- patients who do not have access to smartphone
- patients who do not speak English or Spanish
- patients with hearing impairment
- patients in homeless situation
- decisionally impaired patients
- presence of ileostomy prior to the surgical procedure
- surgery without intestinal resection
Sites / Locations
- Stanford Health Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Arm
High Fiber/low fat
Fermented
Arm Description
Standard care - patients will not receive specific dietary advice.
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
Outcomes
Primary Outcome Measures
Changes in gut microbiome before surgery with short-term pre-operative diet intervention
Compare baseline and pre-op stool sample and analyze for change in microbiome
Secondary Outcome Measures
Changes in gut microbiome after surgery with short-term pre-operative diet intervention
Compare baseline and post-op stool samples and analyze for differences in microbiome
Adherence to short-term pre-operative diet intervention
Adherence to the diet in intervention will be assessed with surveys combined with food logging, to determine the percentage of meals that were in line with the recommended diet.
Surgical outcomes with short-term pre-operative diet intervention
Comprehensive Complication Index will be used to determine surgical complications occurring within a 30 day period after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05027763
Brief Title
Effect of Preoperative Diet on Perioperative Gut Microbiome
Official Title
Can Low-fat/High-fiber or Fermented Diet Modulate the Gut Microbiome to Improve Surgical Outcomes?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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 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 checked daily through a digital application (Cronometer) and telephone calls. Stool samples will be collected in five timepoints: at the beginning of the study, after the dietary intervention, during surgery, upon the first bowel movement after 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 microbiome.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard care - patients will not receive specific dietary advice.
Arm Title
High Fiber/low fat
Arm Type
Experimental
Arm Description
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
Arm Title
Fermented
Arm Type
Experimental
Arm Description
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
Intervention Type
Behavioral
Intervention Name(s)
high-fiber/low fat
Intervention Description
high fiber/low fat preoperative diet
Intervention Type
Behavioral
Intervention Name(s)
fermented
Intervention Description
fermented preoperative diet
Primary Outcome Measure Information:
Title
Changes in gut microbiome before surgery with short-term pre-operative diet intervention
Description
Compare baseline and pre-op stool sample and analyze for change in microbiome
Time Frame
two weeks prior to surgery
Secondary Outcome Measure Information:
Title
Changes in gut microbiome after surgery with short-term pre-operative diet intervention
Description
Compare baseline and post-op stool samples and analyze for differences in microbiome
Time Frame
two weeks prior to surgery until 1 month after surgery
Title
Adherence to short-term pre-operative diet intervention
Description
Adherence to the diet in intervention will be assessed with surveys combined with food logging, to determine the percentage of meals that were in line with the recommended diet.
Time Frame
two weeks prior to surgery
Title
Surgical outcomes with short-term pre-operative diet intervention
Description
Comprehensive Complication Index will be used to determine surgical complications occurring within a 30 day period after surgery
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
undergoing major abdominal colorectal surgery with intestinal resection in 2 or more weeks
Exclusion Criteria:
patients who do not have access to smartphone
patients who do not speak English or Spanish
patients with hearing impairment
patients in homeless situation
decisionally impaired patients
presence of ileostomy prior to the surgical procedure
surgery without intestinal resection
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Preoperative Diet on Perioperative Gut Microbiome
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