NCT07732582Not yet recruiting
Sjogren's Mini-Pill Oral and Gut Microbiome Study
Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 23 Jul 2026
- Start date
- 31 Aug 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Tufts University
- Diseases
- Sjögren's disease
- NCT number
- NCT07732582
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 31 Aug 2026 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Presence of active disease of the hard or soft oral tissues.
Other
- 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
Who the study is looking for
- 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.
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tufts University School of Dental Medicine Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.