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

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Other: Dietary pattern : High-fiber diet rich in PUFA; Other: Dietary pattern: Standard diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04869956

2021-2-7-HCUVA

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard diet

Other group

Description:

Dietary pattern: Standard diet

Treatment:

Other: Dietary pattern: Standard diet

High - Fiber diet rich in PUFA

Experimental group

Description:

High - Fiber diet rich in PUFA

Treatment:

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