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Dietary Supplement on the Intestinal Microbiota in Patients With Colon Cancer — TERATROFO  

Colon Cancer Clinical Trial

Official title:
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.

Clinical Trial 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

Clinical Trial Description

Introduction: The alteration in the microbiota plays a fundamental role in the promotion and progression of colon cancer due to various pathways such as inflammation and oxidative stress. The use of substances with anti-inflammatory and antioxidant effect could be useful for the treatment of this disease. Methodology: Prospective randomized clinical trial, with three parallel groups and double blind. Patients with stage II or III colon neoplasia who are going to receive post-surgical chemotherapy will be included. Patients will be randomized to one of the following groups: group 1 (25 patients): product with hydroxytyrosol extract; group 2 (25 patients): product with curcumin and selenium extract. Group 3 (25 patients): placebo. Before starting chemotherapy, stool and blood samples will be taken, and gastrointestinal symptoms, quality of life, symptoms of anxiety-depression and evaluation of nutritional status will be assessed. When starting chemotherapy, they will start with a daily intake of the assigned dietary supplement. At 3 months ± 2 weeks after starting chemotherapy (at least 2 weeks must have passed since the last chemotherapy of the fourth cycle), the same assessment will be made as in the initial visit, in addition to recording adherence to the intervention dietary supplement and new health problems that have appeared since the previous visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05472753
Study type Interventional
Source Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Contact Ignacio Ruiz García,, MD, PhD.
Phone 951290343/951030117
Email nach1991@gmail.com
Status Recruiting
Phase N/A
Start date November 16, 2022
Completion date June 30, 2023
View Details
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