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Sjogren's Mini-Pill Oral and Gut Microbiome Study

Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares microbes, such as bacteria, in the gut, stool, mouth, and gums of adults with Sjögren's disease and healthy adults. It uses tiny pills that participants swallow to collect gut samples and includes people enrolled in a larger gut microbe study.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Healthy group: Be enrolled in the parent mini-pill study at Tufts University and agree to share your data.
  • Healthy group: Understand the study and sign a form agreeing to take part.
  • Sjögren's group: Be an adult diagnosed with Sjögren's disease under the 2016 American European criteria.
  • Both groups: Agree to give saliva and plaque samples from the deepest space between your teeth and gums.
  • Sjögren's group: Be able and willing to collect stool at home and recover the gut-sampling pills.

Who can't join

  • Healthy group: Not enrolled in the parent study, or unable to understand or unwilling to sign the agreement form.
  • Healthy group: Need antibiotics before dental work to prevent infection. In this case, only saliva will be collected, not gum plaque.
  • Healthy group: Have an active disease affecting the teeth or other mouth tissues.
  • Healthy group: Have a history of disorders of the glands that make saliva, such as Sjögren's or sarcoidosis, or past radiation treatment to the head or neck.
  • Healthy group: Need new dental or gum treatment during the study, including deep cleaning or antibiotic rinsing under the gums.
  • Sjögren's group: Are pregnant or breastfeeding.
  • Sjögren's group: Need antibiotics before dental work to prevent infection.
  • Sjögren's group: Have HIV/AIDS or sarcoidosis (a disease that causes tissue swelling), or have had radiation treatment to the head or neck.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Group 1: Control 1. 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. 2. Willing to provide saliva and periodontal plaque from the deepest periodontal pocket. 3. Able to understand study requirements and procedures, and willing to sign informed consent prior to participation. Group 2: Sjogren's Cohort 1. Adult Sjogren's Disease participants diagnosed according to the 2016 American European criteria 2. Willing to donate saliva and periodontal plaque from the deepest periodontal pocket. 3. Able and willing to perform home stool collection and recovery of GI sampling capsules. Exclusion Criteria Control Group: 1. Those not participating in parent study, "Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling" at HNRCA. 2. Unable to understand or unwilling to sign the informed consent form. 3. 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. 4. Presence of active disease of the hard or soft oral tissues. 5. History of salivary gland disorders, such as Sjögren's syndrome, sarcoidosis, or prior head and neck radiation therapy. 6. 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: 1. Pregnant or breast feeding 2. Requiring antibiotic prophylaxis before dental procedures 3. HIV/AIDS, sarcoidosis, or prior head and neck radiation therapy.

Study sites (1)

MA