Can High-fiber or Fermented Diet Modulate the Gut Microbiome to Improve Surgical Outcomes?
| Registry | NCT05027763 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 60 (Actual) |
| Sponsor | Stanford University (Other) |
| Conditions | Surgical Site Infection |
| Interventions | high-fiber, fermented (Behavioral) |
| Dates | start 2022-03-11, primary completion 2024-11-02, completion 2024-11-13, first posted 2021-08-30, last updated 2026-10-20 |
| Locations | 1 site in United States |
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All trials for Surgical Site Infection All trials of high-fiber All trials of fermented
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.
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 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 (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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Arm | No intervention | Standard care - patients will not receive specific dietary advice. | |
| High Fiber | Experimental | Behavioral: high-fiber | Patients will receive sample meals and education/support, will be asked to follow this diet for 10-14 days. |
| Fermented | Experimental | Behavioral: fermented | Patients will receive sample meals and education/support, will be asked to follow this diet for 10-14 days. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * undergoing major abdominal colorectal surgery with intestinal resection in 2 or more weeks Exclusion Criteria: * no access to smartphone * patients who do not speak English or Spanish * houseless patients * decisionally impaired patients * presence of ileostomy prior to the surgical procedure * creation of end ileostomy at the time of procedure * surgery without intestinal resection * baseline consumption of more than 20g of fiber per ay, or more than 2 servings of fermented food per day
| Facility | City | Country | Status |
|---|---|---|---|
| Stanford Health Care | Stanford, California | United States |