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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Control GroupActive comparator 1 intervention

Group B: Sjogren's GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Microbial

The primary outcome will be overall microbial community composition

Time frame

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.

Time frame

3 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: