Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.

NCT07290023 | Completed

• 1 other identifier: PR(AG)400/2020
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  1 year

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gastroenterology consultations patients.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Lara Aguilera Castro

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (3)

• 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.

  PMID: 34506740 BACKGROUND

• 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.

  PMID: 29702117 RESULT

• 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.

  PMID: 36038569 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples from saliva, and feces will be collected.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lara Aguilera Castro

  Vall d'Hebron Research Institute Barcelona, Spain, 08035

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 11, 2021
• Primary Completion: December 31, 2023
• Study Completion: January 2, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)