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high-fiber/low fat for Surgical Site Infection

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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in gut microbiome alpha and beta diversity according to pre-operative diet intervention
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,333,990 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for patients to participate in this research project?

"Per the information on clinicaltrials.gov, this study is closed for recruitment as of April 7th 2022. On March 1st 2021 was when it posted to the website and attracted interest from prospective participants. Although recruiting has stopped, there are 71 other trials that need volunteers at this moment in time."

Answered by AI
~13 spots leftby Dec 2024