Studying mouth and gut bacteria in Sjögren's disease with a swallowable mini-pill
Uses a swallowable mini-pill to sample gut and mouth bacteria in adults with Sjögren's disease.
Plain-language title generated from the registry record
Registry title: Sjogren's Mini-Pill Oral and Gut Microbiome Study
Key facts
- Where
- Boston, United StatesSee the site
Where in United States
- Tufts University School of Dental MedicineBoston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tufts University
- Trial code
- NCT07732582
- Record updated
- 29 July 2026
- Original description
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 studyRead full original descriptionShow less
Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology
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
Inclusion: 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.
Exclusion: 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; History of salivary gland disorders, such as Sjögren's syndrome, sarcoidosis, or prior head and neck radiation therapy; HIV/AIDS, sarcoidosis, or prior head and neck radiation therapy; Presence of active disease of the hard or soft oral tissues; 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; 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.