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NCT Number: NCT06349590

Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery

A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized High-fiber/low-fat meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have histologically or cytologically confirmed colorectal adenocarcinoma.
  • Planned for primary tumor resection at the University of Chicago Medicine ≥21 from date of obtained informed consent. Patients with metastatic disease but undergoing primary site resection are eligible for the study.
  • Age ≥18 years.
  • Patients <18 years of age, children are excluded from this study, because they have unique nutritional requirements that might not be met by with the standardized diet. The food in the diet is designed for adults and would not be feasible for children, especially those attending school. In addition, colon cancer is extremely rare in children.
  • May have received neoadjuvant therapy (chemotherapy, radiation).
  • Patients with Hepatic arterial infusion (HAI) pumps are considered eligible.
  • Ability to understand and willing to sign an informed consent, participate in the dietary intervention, collect stools, donate blood, and complete a pre-nutritional evaluation and compliance/patient satisfaction survey.

Exclusion criteria

  • Previous ostomy (ileostomy or colostomy) or definitive plan for an ostomy (ileostomy or colostomy) during the procedure.
  • Antibiotic exposure within 60 days before diet initiation. Antibiotic exposure is defined as a 'course of treatment to treat an infection'. Prophylactic antibiotics prior to a procedure is okay.
  • Prebiotic/Probiotic exposure within 60 days before diet initiation.
  • Concomitant separate malignancy.
  • Allergy to perioperative medications (oral neomycin/metronidazole for bowel preparation, intraoperative prophylactic intravenous cefazolin and metronidazole).
  • Patients who are pregnant are not eligible for the study. Pregnant women are excluded from this study because the preoperative diet is not specifically formulated to meet the specific nutritional requirements during the prenatal period.
  • History of inflammatory bowel disease
  • Severe food allergies precluding the ability to tolerate the standardized dietary intervention.
  • Patients with uncontrolled intercurrent illness

Treatment and study plan

High-fiber/low-fat meals

Dietary Supplement

Meals with Low fat/High fiber

Primary outcomes

  1. Change in lab values of the dietary intervention on the collagenolytic potential of the microenvironment.

    Time frame: At baseline on Day 1 until final values collected on 6 months post-op visit.

    To assess whether the dietary intervention significantly changed the collagenase activity, the site will compare each subject's baseline and final values.

Secondary outcomes

  1. Change in stool samples of the dietary intervention on components of the urokinase-type plasminogen activator (uPA) plasminogen system.

    Time frame: At baseline on Day 1 until final values collected on 6 months post-op visit.

    The site will compare the presence of active-uPA, active- Matrix metalloproteinase-9 (MMP9), and plasminogen in stool samples before and after diet intervention. These assays will be performed in the Shogan Laboratory using western blot and zymography.

  2. Change in stool samples in the metagenomic response of the gut microbiome to the dietary intervention.

    Time frame: At baseline on Day 1 until final values collected on 6 months post-op visit.

    There will be an investigation in the stool associated metagenomics in subjects before and after intervention. During this analysis it will determine the bacterial composition and function, with a particular interest in proteolytic function.

  3. Change in the levels of short-chain fatty acids and bile acids in the metabolomic response to the dietary intervention.

    Time frame: At baseline on Day 1 until final values collected on 6 months post-op visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Shogan, MD

CONTACT

[email protected]

773-732-2260

Teresa Barry

CONTACT

[email protected]

773-702-5681

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

A Phase 1/2 Study of Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery (The DIET Trial)

Acronym: DIET

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 5, 2024
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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