Colorectal CancerNCT04869956
Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery
A study testing Dietary pattern : High-fiber diet rich in PUFA and Dietary pattern: Standard diet in people with Colorectal Cancer, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Dietary pattern : High-fiber diet rich in PUFA and Dietary pattern: Standard diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-80 years old.
- After clinical diagnosis of CRC (stage I-III), the doctor has recommended and arranged for CRC surgery
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Biomedical Research Institute of Murcia (IMIB-Arrixaca)
Murcia, 30120
Bruno Ramos Molina, bruno.ramos@imib.es
About this study
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
- Being tested
- Dietary pattern : High-fiber diet rich in PUFA, Dietary pattern: Standard diet
- Keywords
- Microbiome, Surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary pattern : High-fiber diet rich in PUFAOther
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
Dietary pattern: Standard dietOther
standard nutritional recommendations
| Study group | Role | What they receive |
|---|---|---|
| Standard diet | Other | Dietary pattern: Standard diet Receives: Other: Dietary pattern: Standard diet |
| High - Fiber diet rich in PUFA | Experimental | High - Fiber diet rich in PUFA Receives: Other: Dietary pattern : High-fiber diet rich in PUFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anastomotic leakage
Number of anastomotic leakage
Measured: 360 Days from Baseline
Surgical site infection
Number of site infection
Measured: 360 Days from Baseline
Secondary outcomes (4)
Change in gut microbiome composition
changes in gut microbiota composition by 16S rRNA gene sequencing
Measured: 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)
Measured: 360 Days from Baseline
Length of hospitalization after surgery
Number of days
Measured: 360 Days from Baseline
Recurrences of CRC after surgery
Number of recurrences
Measured: 360 Days from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Jun 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open, controlled, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869956
- Sponsor's protocol ID
- 2021-2-7-HCUVA
- Status last verified
- Jul 2022
- First submitted
- 28 Apr 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery
- ClinicalTrials.gov ID
- NCT04869956
- Acronym / sponsor ID
- 2021-2-7-HCUVA
- Conditions
- Colorectal Cancer
- Keywords
- Microbiome, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open, controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard diet | Other | Other: Dietary pattern: Standard dietDietary pattern: Standard diet |
| High - Fiber diet rich in PUFA | Experimental | Other: Dietary pattern : High-fiber diet rich in PUFAHigh - Fiber diet rich in PUFA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18-80 years old.
- After clinical diagnosis of CRC (stage I-III), the doctor has recommended and arranged for CRC surgery
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary pattern : High-fiber diet rich in PUFAHigh-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 | Other | High - Fiber diet rich in PUFA |
| Dietary pattern: Standard dietstandard nutritional recommendations | Other | Standard diet |
Primary outcome
Rate of anastomotic leakage
Time frame: 360 Days from Baseline
Number of anastomotic leakage
Surgical site infection
Time frame: 360 Days from Baseline
Number of site infection
4 secondary outcomes
Change in gut microbiome composition
Time frame: 360 Days from Baseline
Serum levels of inflammation markers
Time frame: 360 Days from Baseline
Length of hospitalization after surgery
Time frame: 360 Days from Baseline
Recurrences of CRC after surgery
Time frame: 360 Days from Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary pattern : High-fiber diet rich in PUFA and Dietary pattern: Standard diet in people with Colorectal Cancer, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Ramos Molina (968369500, bruno.ramos@imib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anastomotic leakage (time frame: 360 Days from Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.