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

Colorectal Cancer Clinical Trial

— DIET  

Official 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06349590
• Other study ID #: IRB24-0373
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2024
• Est. completion date: April 2029

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: Benjamin Shogan, MD
• Phone: 773-732-2260
• Email: bshogan[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 plant-based low fat/ high-fiber 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• History or current ileostomy or colostomy.
• Antibiotic exposure within 90 days before diet initiation.
• Prebiotic exposure within 90 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.
• History of inflammatory bowel disease
• Severe food allergies precluding the ability to tolerate the standardized dietary intervention.
• Patients with uncontrolled intercurrent illness
• 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
• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Recurrence

Intervention

Dietary Supplement:
• Plant-Based Meals
Plant-Based Meals with Low fat/High fiber

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the presence of active-urokinase-type plasminogen activation (uPA) stool samples before and after diet intervention using western blot and zymography.		At baseline on Day 1 until final values collected on 30 days post-op visit.
Secondary	Change of the presence of active- Matrix Metalloproteinase-9 (MMP9) in stool samples before and after diet intervention using western blot and zymography.		At baseline on Day 1 until final values collected on 30 days post-op visit.
Secondary	Change of the presence of plasminogen in stool samples before and after diet intervention using western blot and zymography.		At baseline on Day 1 until final values collected on 30 days post-op visit.
Secondary	Change of the stool associated metagenomics in subjects before and after intervention.	We will determine the bacterial composition and function, with a particular interest in proteolytic function.	At baseline on Day 1 until final values collected on 30 days post-op visit.
Secondary	Change of the levels of short-chain fatty acids and bile acids between pre- and post- intervention stool samples.		At baseline on Day 1 until final values collected on 30 days post-op visit.