NCT07290023已完成不适用
Characterization of the Oral and Gut Microbiota in Individuals With Serrated Polyposis Syndrome.
Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年1月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Characterization of Intestinal Microbiota through 16S Sequencing
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •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.
结局指标
主要结局
Characterization of Intestinal Microbiota through 16S Sequencing
时间窗: 1 year
Characterization of Intestinal Microbiota through 16S Sequencing
Characterization of Oral Microbiota through 16S Sequencing
时间窗: 1 year
Characterization of Oral Microbiota through 16S Sequencing
次要结局
- Quantitative Polymerase Chain Reaction (qPCR) from F. nucleatum.(1 year)
研究者
研究点 (1)
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