Recruiting
Phase 1
Phase 2

Preoperative Diet

Sponsor:

University of Chicago

Code:

NCT06349590

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-fiber/low-fat meals

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer

Study ID

NCT06349590

Start date

Jun 27, 2024

Status verified date

Nov, 2025

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Dietary Intervention Participants

Subjects will be provided 21 days of standardized plant-based low fat/ high-fiber meals and complete a food diary up until lunch on the day prior to surgery.

Interventions

High-fiber/low-fat meals

Meals with Low fat/High fiber

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Benjamin Shogan, MD

773-732-2260bshogan@bsd.uchicago.edu

Teresa Barry

773-702-5681tbarry@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Benjamin Shogan, MD

773-732-2260bshogan@bsd.uchicago.edu

Leila Yazdanbakhsh

773-834-6087leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator:

Benjamin Shogan, MD

More Information

Sponsor

University of Chicago

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-11-05.