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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets might improve recovery from major abdominal surgery. Researchers aim to determine if a high-fiber/low-fat diet or a diet rich in fermented foods can alter the gut microbiome and lead to better surgical outcomes. Participants will either follow one of these diets or receive regular care without dietary changes. Suitable candidates for this trial are those scheduled for major abdominal colorectal surgery involving intestinal resection in two or more weeks. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery for future patients.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fermented foods and synbiotics (a mix of beneficial bacteria and the nutrients they need) can help reduce inflammation, potentially aiding the body in healing better after surgery. Studies suggest that consuming these foods around the time of surgery may lower the risk of infections.

For those considering a high-fiber, low-fat diet, research indicates that increasing fiber intake before surgery may reduce the risk of complications afterward. This diet might also help prevent issues like infections or slow healing.

Both the fermented food diet and the high-fiber/low-fat diet have been studied for their safety and benefits, particularly for surgical patients. While diets can affect individuals differently, these studies suggest they are generally safe and could aid in recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Preoperative Diet for Surgical Outcomes trial because it explores how dietary changes can potentially enhance surgical recovery. Unlike typical preoperative care that doesn't specifically address diet, this trial investigates two innovative dietary approaches: a high-fiber/low-fat diet and a fermented diet. These approaches are unique because they focus on optimizing gut health and reducing inflammation, which could lead to faster recovery times and better overall outcomes for surgical patients. By examining these dietary interventions, researchers hope to uncover new, non-invasive methods to improve patient recovery without relying on medications or more invasive procedures.

What evidence suggests that these diets could improve surgical outcomes?

This trial will compare the effects of a fermented diet and a high-fiber, low-fat diet on surgical outcomes. Studies have shown that fermented foods, containing both prebiotics and probiotics, may reduce inflammation more effectively than either alone. This reduction in inflammation can aid recovery after surgery. Research suggests that preparing for surgery with a high-fiber, low-fat diet can lower the risk of complications after procedures like colorectal cancer surgery by positively affecting the gut microbiome. These diets have been linked to better healing and fewer complications. Both diets aim to improve surgical outcomes by promoting a healthier balance of gut bacteria. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10060133/

Synbiotics and Surgery: Can Prebiotics and Probiotics ... Synbiotics and fermented foods may have an even greater anti-inflammatory effect than probiotics or prebiotics alone. Recent data suggest that ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916525006057

Preoperative plasma short- and branched-chain fatty acids ... Emerging evidence suggests that nutritional prehabilitation reduces risk of complications after colorectal cancer (CRC) surgery.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36991238/

Can Prebiotics and Probiotics Affect Inflammatory Surgical ... Recent findings: Synbiotics and fermented foods may have an even greater anti-inflammatory effect than probiotics or prebiotics alone. Recent data suggest that ...

4. mdpi.com mdpi.com/2072-6643/16/13/2055

Preoperative Multistrain Probiotic Supplementation Does ... Primary outcomes included excess body weight loss, body weight loss, and excess body mass index loss, with secondary objectives focusing on metabolic profiles.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589004223000366

Exploring the roles of intestinal flora in enhanced recovery ... Dietary changes could optimize surgical outcomes through effects on the gut microbiota. ERAS recommends preoperative oral carbohydrate beverages ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8209565/

Association of Habitual Preoperative Dietary Fiber Intake ... In this cohort study, higher dietary fiber intake before surgery was associated with a lower risk of any or surgical postoperative complications in patients ...

7. mdpi.com mdpi.com/2072-6643/17/9/1522

Effect of Preoperative Inflammatory Diet on Clinical and ... In this study, the group that consumed a more inflammatory diet showed significantly worse postoperative oncologic outcomes and greater postoperative ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0261561416312900

Effects of perioperative supplementation with pro-/ ... For surgical patients, perioperative supplementation with pro-/synbiotics is effective in preventing or controlling SSI and other infectious complications.

9. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-021-02035-6

The effects of preoperative intestinal dysbacteriosis on ... Clinical outcomes were postoperative infections and anastomotic leakage within 30 days after surgery. Results. At the preoperative assessment, ...