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

NCT04869956 | Unknown

• 1 other identifier: 2021-2-7-HCUVA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

Microbiome; Surgery

Outcome Measures

Primary Outcomes (2)

• Rate of anastomotic leakage

  Number of anastomotic leakage

  360 Days from Baseline

• Surgical site infection

  Number of site infection

  360 Days from Baseline

Secondary Outcomes (4)

• Change in gut microbiome composition

  360 Days from Baseline

• Serum levels of inflammation markers

  360 Days from Baseline

• Length of hospitalization after surgery

  360 Days from Baseline

• Recurrences of CRC after surgery

  360 Days from Baseline

Study Arms (2)

Standard diet

OTHER

Dietary pattern: Standard diet

Other: Dietary pattern: Standard diet

High - Fiber diet rich in PUFA

EXPERIMENTAL

High - Fiber diet rich in PUFA

Other: Dietary pattern : High-fiber diet rich in PUFA

Interventions

Dietary pattern : High-fiber diet rich in PUFA OTHER

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

High - Fiber diet rich in PUFA

Dietary pattern: Standard diet OTHER

standard nutritional recommendations

Standard diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.).

Sponsors & Collaborators

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

Study Sites (1)

Biomedical Research Institute of Murcia (IMIB-Arrixaca)

Murcia, 30120, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Fatty Acids, Unsaturated

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids

Central Study Contacts

Bruno Ramos Molina

CONTACT

968369500; bruno.ramos@imib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open, controlled, randomized clinical trial

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: June 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: June 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

ES (1)