Preoperative Diet for Surgical Outcomes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-English/Spanish speakers, Houseless, Decisionally impaired, Ileostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for English or Spanish-speaking individuals scheduled for major abdominal colorectal surgery with intestinal resection in at least two weeks. It excludes those who are hearing impaired, without smartphone access, homeless, decisionally impaired, lacking an ileostomy prior to surgery, or having a procedure without intestinal resection.

Inclusion Criteria

I am scheduled for major bowel surgery in more than 2 weeks.

Exclusion Criteria

Houseless patients

I have an ileostomy.

I am unable to make medical decisions for myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or remote)

Enrollment

Participants are enrolled and randomized to dietary interventions

1 week

1 visit (in-person or remote)

Intervention

Participants follow assigned diet (low-fat/high-fiber, high-fermented, or control) for 10-14 days before surgery

2 weeks

Regular check-ins (remote)

Surgery

Participants undergo abdominal surgery and samples are collected

1 day

1 visit (in-person)

Follow-up

Participants are monitored for surgical outcomes and microbiome changes for 30 days post-surgery

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Fermented Diet
• High-Fiber/Low Fat Diet

Trial Overview The study investigates the impact of preoperative diets on the gut microbiome and surgical outcomes. Participants will follow specific diets that are either fermented or high-fiber/low-fat before their abdominal surgeries to see if these can improve recovery and reduce infections.

Participant Groups

Group I: High Fiber/low fat Experimental Treatment 1 Intervention

Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.

Group II: Fermented Experimental Treatment 1 Intervention

Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.

Group III: Control Arm Active Control 1 Intervention

Standard care - patients will not receive specific dietary advice.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+