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Preoperative Diet for Surgical Outcomes

N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgery date until 1 month after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the gut microbiome of people having surgery and whether certain diets can change the microbiome in a way that leads to better surgical outcomes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated, potential side effects may include digestive discomfort due to dietary changes such as bloating or gas from high-fiber intake and possible nutritional deficiencies if the diet lacks essential nutrients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in gut microbiome alpha and beta diversity according to pre-operative diet intervention
Secondary study objectives
Change in gut microbiome alpha and beta diversity after surgery according to pre-operative diet
Frequency and severity of surgical complications according to pre-operative diet

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: High Fiber/low fatExperimental Treatment1 Intervention
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
Group II: FermentedExperimental Treatment1 Intervention
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
Group III: Control ArmActive Control1 Intervention
Standard care - patients will not receive specific dietary advice.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,468 Previous Clinical Trials
17,496,222 Total Patients Enrolled
~0 spots leftby Dec 2024
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