Sjogren's Mini-Pill Oral and Gut Microbiome Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mini-Pill.
- Who it may be relevant to
- Registry conditions: Sjogren's Syndrome. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology
Overview
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
Interventions
- Device Mini-Pill
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.
Primary outcome measures
- Microbial [Time frame: 3-8 weeks]
- Sjogren's Microbiome Relationship [Time frame: 3 weeks]
Eligibility criteria
Inclusion criteria
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 criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Tufts University School of Dental Medicine — Boston
Identifiers
NCT: NCT07732582 · STUDY00006388