Sjogren's Mini-Pill Oral and Gut Microbiome Study
ConditionSjogren's Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorTufts University
About this trial
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
Eligibility criteria
Qualifiers
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.
Adult Sjogren's Disease participants diagnosed according to the 2016 American European criteria
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mini-Pill
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov