Dietary Supplement on the Intestinal Microbiota in Patients with Colon Cancer
TERATROFO
Effect of a Dietary Supplement with Antioxidant and Anti-inflammatory Properties on the Intestinal Microbiota in Patients with Colon Cancer. Randomized, Placebo-controlled Clinical Trial. TERATROPHO Study.
1 other identifier
interventional
75
1 country
1
Brief Summary
Effect of a dietary supplement with antioxidant and anti-inflamatory properties on the intestinal microbiota in patients with colon cancer. Ramdonized placebo controlled clinical trial. Teratrophic study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
November 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedFebruary 12, 2025
February 1, 2025
1.3 years
May 4, 2022
February 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the alpha diversity index (Shannon)
This diversity index is a quantitative indicator of the number of different bacteria that are present in a stool sample, taking into account the uniformity in the distribution of these bacteria in these species. Diversity index value increases both when the number of species increases and when evenness increases. The Shannon index is a well-known diversity index used in microecological studies. The higher the Shannon index value, the higher the community diversity. It is calculated as: H = -Σpi \* ln(pi), where "H" is the Shannon Diversity Index. "Σ" is a Greek symbol that means "sum". "ln" is natural log. "pi" is the proportion of the entire community made up of species i. The minimum value the Shannon diversity index can take is 0. Such a number would tell us that there is no diversity - only one species is found in that habitat. There is no upper limit to the index.
From baseline to 3 months about 2 weeks after starting chemotherapy
Secondary Outcomes (60)
Change in weight
From baseline to 3 months about 2 weeks after starting chemotherapy
Change in height
From baseline to 3 months about 2 weeks after starting chemotherapy
BMI (body mass index) changes
From baseline to 3 months about 2 weeks after starting chemotherapy
Mediterranean diet adherence questionnaire
From baseline to 3 months about 2 weeks after starting chemotherapy
Maximum and mean value of 3 measurements in dominant hand dynamometry
From baseline to 3 months about 2 weeks after starting chemotherapy
- +55 more secondary outcomes
Study Arms (3)
Group 1 (25 patients)
EXPERIMENTALA product of the company DCOOP, with hydroxytyrosol extract
Group 2 (25 patients)
EXPERIMENTALA product of the company Indukern, with extract of curcumin and selenium
Group 3 (25 patients)
PLACEBO COMPARATORPlacebo
Interventions
Intervention group will receive a nutritional formula from DCOOP (Spain).
Intervention group will receive a nutritional formula from Indukern (Spain).
Control group will receive a placebo (product loading substance)
Eligibility Criteria
You may qualify if:
- Diagnosis of stage II or III colo neoplasia
- Indication of adjuvant chemotherapy according to the Protocols for the diagnosis and treatment of cancer of the Intercenter Clinical Management Unit
- Sign the informed consent
You may not qualify if:
- Systemic autoimmune diseases (systemic lupus erythematosus, antiphospholipid syndrome, Sjögren's syndrome, progressive systemic sclerosis -scleroderma-, idiopathic inflammatory myopathies -myositis-, vasculitis, Behçet's disease, relapsing polychondritis, etc.)
- Mellitus diabetes type 1
- Previous gastrointestinal resections, except for appendectomy or surgery required to treat colon neoplasia
- Chronic intestinal pathologies (inflammatory bowel disease, celiac disease, lymphangiectasias)
- Continued consumption of probiotics, with the exception of dairy products or other natural fermented foods
- Chronic and continued use of NSAIDs or corticosteroids
- Allergy to any component of the product under investigation
- Pregnancy
- Mean consumption of \> 3 UBE of alcohol per day
- Previous or concomitant neoplasia, unless curative treatment was received and ≥5 years have passed free of disease
- ECOG scale greater than or equal to 3 at the start of the clinical trial
- Grade 3-4 neuropathy that limits the use of oxaliplatin.
- History of familial adenomatous polyposis mediated by the APC gene or by Lynch syndrome (mutations MLH1, MSH2, PMS2, MSH6).
- Patients with partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), which causes poor metabolism and the use of fluoropyrimidines is contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Regional Universitario de Málaga
Málaga, Málaga, 29009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Olveira Fuster, MD, PhD.
Hospital Regional Universitario de Málaga, FIMABIS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2022
First Posted
July 25, 2022
Study Start
November 16, 2022
Primary Completion
February 27, 2024
Study Completion
May 31, 2024
Last Updated
February 12, 2025
Record last verified: 2025-02