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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dietary pattern : High-fiber diet rich in PUFA
Dietary pattern: Standard diet
Sponsored by
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Microbiome, Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.).

Sites / Locations

  • Biomedical Research Institute of Murcia (IMIB-Arrixaca)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard diet

High - Fiber diet rich in PUFA

Arm Description

Dietary pattern: Standard diet

High - Fiber diet rich in PUFA

Outcomes

Primary Outcome Measures

Rate of anastomotic leakage
Number of anastomotic leakage
Surgical site infection
Number of site infection

Secondary Outcome Measures

Change in gut microbiome composition
changes in gut microbiota composition by 16S rRNA gene sequencing
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)
Length of hospitalization after surgery
Number of days
Recurrences of CRC after surgery
Number of recurrences

Full Information

First Posted
April 28, 2021
Last Updated
July 25, 2022
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04869956
Brief Title
Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery
Official Title
Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Microbiome, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open, controlled, randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard diet
Arm Type
Other
Arm Description
Dietary pattern: Standard diet
Arm Title
High - Fiber diet rich in PUFA
Arm Type
Experimental
Arm Description
High - Fiber diet rich in PUFA
Intervention Type
Other
Intervention Name(s)
Dietary pattern : High-fiber diet rich in PUFA
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Dietary pattern: Standard diet
Intervention Description
standard nutritional recommendations
Primary Outcome Measure Information:
Title
Rate of anastomotic leakage
Description
Number of anastomotic leakage
Time Frame
360 Days from Baseline
Title
Surgical site infection
Description
Number of site infection
Time Frame
360 Days from Baseline
Secondary Outcome Measure Information:
Title
Change in gut microbiome composition
Description
changes in gut microbiota composition by 16S rRNA gene sequencing
Time Frame
360 Days from Baseline
Title
Serum levels of inflammation markers
Description
Blood samples will be used to determine markers of inflammation (IL-6, IL-1β, IL-10 and TNFα), and markers of intestinal permeability (zonulin)
Time Frame
360 Days from Baseline
Title
Length of hospitalization after surgery
Description
Number of days
Time Frame
360 Days from Baseline
Title
Recurrences of CRC after surgery
Description
Number of recurrences
Time Frame
360 Days from Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Ramos Molina
Phone
968369500
Email
bruno.ramos@imib.es
Facility Information:
Facility Name
Biomedical Research Institute of Murcia (IMIB-Arrixaca)
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Ramos Molina
Email
bruno.ramos@imib.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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