R-2487 in Patients With Sjogren's Syndrome (SS) (NCT06297213) | Clinical Trial Compass
Not Yet RecruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SS)
36 participantsStarted 2026-06-01
Plain-language summary
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.
Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Diagnosis of SS according to American-European Consensus Group Criteria
* Able to provide informed consent
* Subjects receiving prednisone (10 mg or less/day) must be on a stable dose for more than 2 weeks
* All male and female subjects who are biologically capable of having children must agree to use medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of investigational product.
* The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden.
Exclusion Criteria:
* No known active overlapping or associated other autoimmune disease
* Prior allogenic or autologous bone marrow or organ transplantation
* Subjects with prior irradiation to the head and neck, including radioactive iodine treatment for hyperthyroidism
* Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
* Subjects with positive results for human immunodeficiency virus (HIV), …
What they're measuring
1
Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration