NCT05472753Completed
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.
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 4 May 2022
- Start date
- 16 Nov 2022
- Primary completion date
- 27 Feb 2024
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Diseases
- Colorectal cancer
- NCT number
- NCT05472753
What you commit to
- Study type: Interventional
- Participants enrolled: 75
- From 16 Nov 2022 to the primary completion date, 27 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrointestinal resections, except for appendectomy or surgery required to treat colon neoplasia
- Chronic and continued use of NSAIDs or corticosteroids
- Previous or concomitant neoplasia, unless curative treatment was received and ≥5 years have passed free of disease
Other illness
- 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
- Chronic intestinal pathologies (inflammatory bowel disease, celiac disease, lymphangiectasias)
- Allergy to any component of the product under investigation
- History of familial adenomatous polyposis mediated by the APC gene or by Lynch syndrome (mutations MLH1, MSH2, PMS2, MSH6).
Other
- Continued consumption of probiotics, with the exception of dairy products or other natural fermented foods
- Pregnancy
- Mean consumption of \> 3 UBE of alcohol per day
- 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.
- Patients with partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), which causes poor metabolism and the use of fluoropyrimidines is contraindicated.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.