Sjogren's Mini-Pill Oral and Gut Microbiome Study

NCT07732582 | Not Yet Recruiting

• 1 other identifier: STUDY00006388
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (2)

• Microbial

  The primary outcome will be overall microbial community composition

  3-8 weeks

• Sjogren's Microbiome Relationship

  To evaluate the relationship of salivary and periodontal plaque microbiomes in the Sjogren's group to their gut and stool microbiome.

  3 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Device: Mini-Pill

Sjogren's Group

EXPERIMENTAL

Adults diagnosed with Sjögren's disease who provide oral microbiome samples and gastrointestinal microbiome samples collected using ingestible mini-pill technology.

Device: Mini-Pill

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.

Control Group; Sjogren's Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Presence of active disease of the hard or soft oral tissues.
• History of salivary gland disorders, such as Sjögren's syndrome, sarcoidosis, or prior head and neck radiation therapy.
• 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
• HIV/AIDS, sarcoidosis, or prior head and neck radiation therapy.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy controls versus individuals with Sjogren's syndrome

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)