Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology
| Registry | NCT07732582 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
| Enrollment | 90 (Estimated) |
| Sponsor | Tufts University (Other) |
| Conditions | Sjogren's Syndrome |
| Interventions | Mini-Pill (Device) |
| Dates | start 2026-08-31 (estimated), primary completion 2027-08-31 (estimated), completion 2028-08-31 (estimated), first posted 2026-07-29, last updated 2026-07-29 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Sjogren's Syndrome All trials of Mini-Pill
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Group | Active comparator | Device: Mini-Pill | Healthy adult controls enrolled in the parent mini-pill gastrointestinal sampling study who provide oral microbiome samples and permit use of gastrointestinal microbiome data collected in the parent study |
| Sjogren's Group | Experimental | Device: Mini-Pill | Adults diagnosed with Sjögren's disease who provide oral microbiome samples and gastrointestinal microbiome samples collected using ingestible mini-pill technology. |
Sex: All, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Tufts University School of Dental Medicine | Boston, Massachusetts | United States |