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

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ClinicalTrials.gov Identifier: NCT04869956
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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


Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Dietary pattern : High-fiber diet rich in PUFA Other: Dietary pattern: Standard diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open, controlled, randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Standard diet
Dietary pattern: Standard diet
Other: Dietary pattern: Standard diet
standard nutritional recommendations

Experimental: High - Fiber diet rich in PUFA
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




Primary Outcome Measures :
  1. Rate of anastomotic leakage [ Time Frame: 360 Days from Baseline ]
    Number of anastomotic leakage

  2. Surgical site infection [ Time Frame: 360 Days from Baseline ]
    Number of site infection


Secondary Outcome Measures :
  1. Change in gut microbiome composition [ Time Frame: 360 Days from Baseline ]
    changes in gut microbiota composition by 16S rRNA gene sequencing

  2. Serum levels of inflammation markers [ Time Frame: 360 Days from Baseline ]
    Blood samples will be used to determine markers of inflammation (IL-6, IL-1β, IL-10 and TNFα), and markers of intestinal permeability (zonulin)

  3. Length of hospitalization after surgery [ Time Frame: 360 Days from Baseline ]
    Number of days

  4. Recurrences of CRC after surgery [ Time Frame: 360 Days from Baseline ]
    Number of recurrences



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869956


Contacts
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Contact: Bruno Ramos Molina 968369500 bruno.ramos@imib.es

Locations
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Spain
Biomedical Research Institute of Murcia (IMIB-Arrixaca) Recruiting
Murcia, Spain, 30120
Contact: Bruno Ramos Molina       bruno.ramos@imib.es   
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
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Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier: NCT04869956    
Other Study ID Numbers: 2021-2-7-HCUVA
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
Microbiome
Surgery
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases