Effect of Preoperative Diet on Perioperative Gut Microbiome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Behavioral: high-fiber/low fat
* Behavioral: fermented


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Standard care - patients will not receive specific dietary advice. | |
| Experimental: High Fiber/low fat<br>Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days. | Behavioral: high-fiber/low fat<br>* high fiber/low fat preoperative diet<br>|
| Experimental: Fermented<br>Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days. | Behavioral: fermented<br>* fermented preoperative diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | two weeks prior to surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | two weeks prior to surgery until 1 month after surgery | 
| 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. | two weeks prior to surgery | 
| 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 | 30 days after surgery |