NCT07732582尚未招募不适用
Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Microbial
研究概览
简要总结
The goal of this observational study is to characterize and compare region-specific gastrointestinal, stool, oral, and periodontal microbiomes in adults with Sjögren's disease and healthy controls using ingestible mini-pill sampling technology. The study will include adults with Sjögren's disease and healthy control participants enrolled in a parent gastrointestinal microbiome study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Control
- •Currently enrolled in and willing to share data from the parent study of "Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling" at Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University.
- •Willing to provide saliva and periodontal plaque from the deepest periodontal pocket.
- •Able to understand study requirements and procedures, and willing to sign informed consent prior to participation.
- •Group 2: Sjogren's Cohort
- •Adult Sjogren's Disease participants diagnosed according to the 2016 American European criteria
- •Willing to donate saliva and periodontal plaque from the deepest periodontal pocket.
- •Able and willing to perform home stool collection and recovery of GI sampling capsules.
排除标准
- •Control Group:
- •Those not participating in parent study, "Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling" at HNRCA.
- •Unable to understand or unwilling to sign the informed consent form.
- •Any medical conditions requiring antibiotic prophylaxis prior to dental procedures (e.g., certain cardiac conditions, prosthetic joints). Upon interviewing the potential subject, no periodontal sample will be taken. Only saliva samples will be taken in these cases.
- •Presence of active disease of the hard or soft oral tissues.
- •History of salivary gland disorders, such as Sjögren's syndrome, sarcoidosis, or prior head and neck radiation therapy.
- •If a subject needs to undergo new dental or periodontal treatment (including scaling, root planing, or antibiotic irrigation) while enrolled in our study
- •Sjogren's Cohort:
- •Pregnant or breast feeding
- •Requiring antibiotic prophylaxis before dental procedures
- •HIV/AIDS, sarcoidosis, or prior head and neck radiation therapy.
结局指标
主要结局
Microbial
时间窗: 3-8 weeks
The primary outcome will be overall microbial community composition
Sjogren's Microbiome Relationship
时间窗: 3 weeks
To evaluate the relationship of salivary and periodontal plaque microbiomes in the Sjogren's group to their gut and stool microbiome.
次要结局
未报告次要终点
研究者
研究点 (1)
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