NCT05472753

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental Treatment, DCOOP Product, Hydroxytyrosol extract	Intervention group will receive a nutritional formula from DCOOP (Spain).
DIETARY_SUPPLEMENT	Experimental Treatment,Indukern product, Curcumin and selenium extract	Intervention group will receive a nutritional formula from Indukern (Spain).
OTHER	Control Treatment	Control group will receive a placebo (product loading substance)

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-02-27
• Completion: 2024-05-31
• First posted: 2022-07-25
• Last updated: 2025-02-12

Locations

1 site across 1 country: Spain