NCT07290023

Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.

Characterization of the Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 126 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

* Background: Serrated polyposis syndrome is the most common colorectal polyposis syndrome. Its pathogenesis is still unknown and its diagnosis is based on clinical criteria. Despite advances in its knowledge, the intestinal microbiota of these patients has not been characterized, nor has the role of Fusobacterium nucleatum in their lesions been evaluated. * Aim: The main objective is to compare the composition of the intestinal and oral microbiota of individuals diagnosed with serrated polyposis syndrome with individuals with sporadic serrated polyps, adenomatous polyps and without polyps. Among the secondary objective is to establish the prevalence of Fusobacterium nucleatum in oral and fecal samples. * Methodology: Observational, case-control and multicenter study. Prospective inclusion for 24 months of all patients diagnosed with serrated polyposis syndrome, associated with three control groups: individuals without polyps, individuals with sporadic serrated lesions and individuals with adenomas. Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.

Conditions

• Colorectal Cancer
• Serrated Polyposis Syndrome
• Intestinal Microbiota

Timeline

• Start date: 2021-01-11
• Primary completion: 2023-12-31
• Completion: 2024-01-02
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: Spain