Sjogren's Mini-Pill Oral and Gut Microbiome Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts University
Study ID
NCT07732582
Status
Not Yet Recruiting

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Conditions

  • Sjogren's Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Mini-Pill — DEVICE
    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.

Study Details

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

Key Dates

First listed
Jul 29, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Control Group
    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
  • Experimental: Sjogren's Group
    Adults diagnosed with Sjögren's disease who provide oral microbiome samples and gastrointestinal microbiome samples collected using ingestible mini-pill technology.

Primary Outcome Measure

Microbial [ Time Frame: 3-8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts University School of Dental MedicineBostonMassachusetts02111-

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Tufts University School of Dental Medicine· Boston, MA

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