Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.

Characterization of the 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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Intestinal Microbiota; Serrated Polyposis Syndrome

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08035
      • Lara Aguilera Castro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Gastroenterology consultations patients.

Description

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.

2) 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Serrated polyposis syndrome; Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
Individuals with sporadic serrated lesions; Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
Individuals with adenomas; Clinical, histological, and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.
Individuals without polyps; Clinical and endoscopic data will be recorded, and biological samples from saliva, and feces will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of Intestinal Microbiota through 16S Sequencing	Characterization of Intestinal Microbiota through 16S Sequencing	1 year
Characterization of Oral Microbiota through 16S Sequencing	Characterization of Oral Microbiota through 16S Sequencing	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Polymerase Chain Reaction (qPCR) from F. nucleatum.	Quantitative Polymerase Chain Reaction (qPCR) from F. nucleatum in saliva and feces.	1 year

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Lara Aguilera Castro, Vall d'Hebron Research Institute Barcelona, Spain, 08035

Publications and helpful links

General Publications

• Cullin N, Azevedo Antunes C, Straussman R, Stein-Thoeringer CK, Elinav E. Microbiome and cancer. Cancer Cell. 2021 Oct 11;39(10):1317-1341. doi: 10.1016/j.ccell.2021.08.006. Epub 2021 Sep 9.
• He X, Wu K, Ogino S, Giovannucci EL, Chan AT, Song M. Association Between Risk Factors for Colorectal Cancer and Risk of Serrated Polyps and Conventional Adenomas. Gastroenterology. 2018 Aug;155(2):355-373.e18. doi: 10.1053/j.gastro.2018.04.019. Epub 2018 Apr 24.
• Avelar-Barragan J, DeDecker L, Lu ZN, Coppedge B, Karnes WE, Whiteson KL. Distinct colon mucosa microbiomes associated with tubular adenomas and serrated polyps. NPJ Biofilms Microbiomes. 2022 Aug 29;8(1):69. doi: 10.1038/s41522-022-00328-6.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PR(AG)400/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No