A swallowable spy pill could unlock Sjögren's secrets
NCT ID NCT07732582
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This study uses a novel ingestible mini-pill to collect bacteria samples from different parts of the gut in people with Sjögren's disease and healthy volunteers. By comparing these samples with mouth and stool bacteria, researchers hope to understand how the microbiome relates to Sjögren's. The goal is to identify unique bacterial patterns that could lead to better diagnosis or treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ingestible mini-pill sampling device
- What this could lead to
- If successful, this could reveal how gut and mouth bacteria differ in Sjögren's disease, pointing toward new ways to diagnose or manage the condition.
- What could go wrong
- This is an early exploratory study focused on observation, not treatment. It may not find clear differences, and the mini-pill technology is still being tested.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tufts University School of Dental Medicine
Boston, Massachusetts, 02111, United States
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