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

Study Overview
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Brief Summary
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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

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Dietary pattern : High-fiber diet rich in PUFA
* Other: Dietary pattern: Standard diet


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open, controlled, randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard diet<br>Dietary pattern: Standard diet | Other: Dietary pattern: Standard diet<br>* standard nutritional recommendations<br>|
| Experimental: High - Fiber diet rich in PUFA<br>High - Fiber diet rich in PUFA | Other: Dietary pattern : High-fiber diet rich in PUFA<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Surgery