Sjogren's SyndromeNCT07732582
Sjogren's Mini-Pill Oral and Gut Microbiome Study
A study testing Mini-Pill in people with Sjogren's Syndrome, run by Tufts University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Mini-Pill
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology
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
- Conditions
- Sjogren's Syndrome
- Being tested
- Mini-Pill
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-PillDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Healthy adult controls enrolled in the parent mini-pill gastrointestinal sampling study who provide oral microbiome samples and permit use of gastrointestinal microbiome data collected in the parent study Receives: Device: Mini-Pill |
| Sjogren's Group | Experimental | Adults diagnosed with Sjögren's disease who provide oral microbiome samples and gastrointestinal microbiome samples collected using ingestible mini-pill technology. Receives: Device: Mini-Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial
The primary outcome will be overall microbial community composition
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Healthy controls versus individuals with Sjogren's syndrome
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732582
- Sponsor's protocol ID
- STUDY00006388
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology
- ClinicalTrials.gov ID
- NCT07732582
- Acronym / sponsor ID
- STUDY00006388
- Conditions
- Sjogren's Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy controls versus individuals with Sjogren's syndrome
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Mini-PillHealthy adult controls enrolled in the parent mini-pill gastrointestinal sampling study who provide oral microbiome samples and permit use of gastrointestinal microbiome data collected in the parent study |
| Sjogren's Group | Experimental | Device: Mini-PillAdults diagnosed with Sjögren's disease who provide oral microbiome samples and gastrointestinal microbiome samples collected using ingestible mini-pill technology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-PillCollection 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. | Device | Control Group, Sjogren's Group |
Primary outcome
Microbial
Time frame: 3-8 weeks
The primary outcome will be overall microbial community composition
Sjogren's Microbiome Relationship
Time frame: 3 weeks
To evaluate the relationship of salivary and periodontal plaque microbiomes in the Sjogren's group to their gut and stool microbiome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-Pill in people with Sjogren's Syndrome, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial (time frame: 3-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.