Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.

* 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Microbiota Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Serrated Polyposis Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lara Aguilera Castro

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals who meet the diagnostic criteria for serrated polyposis syndrome and who have a recent colonoscopy (<3 months) in which at least one serrated lesion is resected (defined as hyperplastic polyp or sessile serrated lesion / polyp) proximal to the rectum ≥ 5 mm.

Individuals who have a recent colonoscopy (<3 months) in which it is at least dry a serrated lesion proximal to the rectum ≥ 5 mm. Must not present ≥ 5 serrated lesions metachronous or synchronous. 3) Individuals who have had a recent colonoscopy (<3 months) with resection of the less one adenoma ≥ 5 mm. 4) Individuals who have had a recent colonoscopy (<3 months) without polyps.

Exclusion criteria

Suspicion of hereditary syndromes of predisposition to CRC (> 20 metachronous adenomas, Familial adenomatous polyposis, Lynch syndrome, Peutz-Jeghers syndrome, Cowden, juvenile polyposis).
Consumption of antibiotics, probiotics or prebiotics in the last 3 months.
Incomplete colonoscopy or with inadequate preparation in some section.
Adenomatous, serrated or indeterminate polyps synchronous in the inclusion colonoscopy except in the group of serrated polyposis syndrome.
Colorectal cancer or hamartomatous polyps in inclusion colonoscopy.

Treatment and study plan

Primary outcomes

Characterization of Intestinal Microbiota through 16S Sequencing

Time frame: 1 year

Characterization of Intestinal Microbiota through 16S Sequencing
Characterization of Oral Microbiota through 16S Sequencing

Time frame: 1 year

Characterization of Oral Microbiota through 16S Sequencing

Secondary outcomes

Quantitative Polymerase Chain Reaction (qPCR) from F. nucleatum.

Time frame: 1 year

Quantitative Polymerase Chain Reaction (qPCR) from F. nucleatum in saliva and feces.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2024
First posted: Dec 17, 2025
Registry last updated: Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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