Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery

The investigators will conduct an open, controlled, randomized clinical trial, in patients with scheduled surgical intervention for CRC in the General Surgery and Digestive System Unit of the Virgen de la Arrixaca University Hospital (Murcia, Spain). All the included individuals must have passed the protocol of the Virgen de la Arrixaca University Hospital to be candidates for elective major surgery for CRC and must sign the informed consent after being informed of the objectives and the methodology of the study. The Helsinki Declaration will be followed during the duration of the project.

Patients will be randomized in a 1:1 ratio after receiving a diagnosis of CRC in the endoscopic evaluation; in the control arm, patients will receive standard nutritional recommendations, while patients in the intervention arm will be advised to follow a high-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Dietary pattern: Standard diet; Other: Dietary pattern : High-fiber diet rich in PUFA

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Ramos Molina; Phone Number: 968369500; Email: bruno.ramos@imib.es

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Recruiting
    • Biomedical Research Institute of Murcia (IMIB-Arrixaca)
    • Contact: Bruno Ramos Molina; Email: bruno.ramos@imib.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18-80 years old.
• After clinical diagnosis of CRC (stage I-III), the doctor has recommended and arranged for CRC surgery

Exclusion Criteria:

• Clinical diagnosis of stage IV CRC.
• Current gastrointestinal illness other than gastroesophageal reflux disease or hemorrhoids (such as celiac disease, inflammatory bowel disease, malabsorptive bariatric procedures, etc.).
• Chronic liver or kidney disease.
• History of cardiac disease.
• Positive genetic test for inherited polyposis syndromes (such as familial adenomatous polyps, hereditary non-polyposis colon cancer syndromes, etc).
• Alcoholism or illicit drug use.
• Antibiotic use within the past 2 months.
• Dietary supplement use including pre- or probiotics within the past month.
• History of intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery.
• Inflammatory or connective tissue disease (such as lupus, scleroderma, rheumatoid arthritis, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Standard diet; Dietary pattern: Standard diet	Other: Dietary pattern: Standard diet; standard nutritional recommendations
EXPERIMENTAL: High - Fiber diet rich in PUFA	Other: Dietary pattern : High-fiber diet rich in PUFA; High-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of anastomotic leakage	Number of anastomotic leakage	360 Days from Baseline
Surgical site infection	Number of site infection	360 Days from Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gut microbiome composition	changes in gut microbiota composition by 16S rRNA gene sequencing	360 Days from Baseline
Serum levels of inflammation markers	Blood samples will be used to determine markers of inflammation (IL-6, IL-1β, IL-10 and TNFα), and markers of intestinal permeability (zonulin)	360 Days from Baseline
Length of hospitalization after surgery	Number of days	360 Days from Baseline
Recurrences of CRC after surgery	Number of recurrences	360 Days from Baseline

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (ACTUAL): May 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Microbiome; Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2021-2-7-HCUVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No