Clinical trial · Interventional
Dietary Supplement on the Intestinal Microbiota in Patients with Colon Cancer
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.
NCT05472753CI-TRIAL-00085892TERATROFOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Treatment | Other | — | UNRESOLVED |
| Experimental Treatment, DCOOP Product, Hydroxytyrosol extract | Dietary Supplement | — | UNRESOLVED |
| Experimental Treatment,Indukern product, Curcumin and selenium extract | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group 1 (25 patients)
- description
- A product of the company DCOOP, with hydroxytyrosol extract
- interventionNames
- Dietary Supplement: Experimental Treatment, DCOOP Product, Hydroxytyrosol extract
- type
- EXPERIMENTAL
- label
- Group 2 (25 patients)
- description
- A product of the company Indukern, with extract of curcumin and selenium
- interventionNames
- Dietary Supplement: Experimental Treatment,Indukern product, Curcumin and selenium extract
- type
- PLACEBO_COMPARATOR
- label
- Group 3 (25 patients)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.