Sjogren's Syndrome
Conditions
Brief summary
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
Interventions
DEVICEMini-Pill
Collection of region-specific gastrointestinal microbiome samples using ingestible mini-pill technology for microbiome characterization and comparison between adults with Sjögren's disease and healthy controls.
Sponsors
Tufts University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Healthy controls versus individuals with Sjogren's syndrome
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Group 1: Control 1. 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. 2. Willing to provide saliva and periodontal plaque from the deepest periodontal pocket. 3. Able to understand study requirements and procedures, and willing to sign informed consent prior to participation. Group 2: Sjogren's Cohort 1. Adult Sjogren's Disease participants diagnosed according to the 2016 American European criteria 2. Willing to donate saliva and periodontal plaque from the deepest periodontal pocket. 3. Able and willing to perform home stool collection and recovery of GI sampling capsules.
Exclusion criteria
Control Group: 1. Those not participating in parent study, "Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling" at HNRCA. 2. Unable to understand or unwilling to sign the informed consent form. 3. 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. 4. Presence of active disease of the hard or soft oral tissues. 5. History of salivary gland disorders, such as Sjögren's syndrome, sarcoidosis, or prior head and neck radiation therapy. 6. 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: 1. Pregnant or breast feeding 2. Requiring antibiotic prophylaxis before dental procedures 3. HIV/AIDS, sarcoidosis, or prior head and neck radiation therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial | 3-8 weeks | The primary outcome will be overall microbial community composition |
| Sjogren's Microbiome Relationship | 3 weeks | To evaluate the relationship of salivary and periodontal plaque microbiomes in the Sjogren's group to their gut and stool microbiome. |
Countries
United States
Outcome results
None listed