Probiotic R-2487 for Sjogren's Syndrome

(R-2487-SjD-01 Trial)

Not yet recruiting at 1 trial location
JS
CF
Overseen ByChristian Freguia, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Rise Therapeutics LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Sjögren's Syndrome who can give consent. Participants must use birth control if they could have children, and women must test negative for pregnancy. Steroid doses should be stable, and no other probiotics are allowed during the study.

Inclusion Criteria

I have been diagnosed with Sjögren's syndrome by standard criteria.
I understand and can agree to the study's procedures and risks.
I am able to have children and will use birth control during the study. If I am a woman, I have a negative pregnancy test before starting treatment.
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What Are the Treatments Tested in This Trial?

Interventions

  • R-2487

Trial Overview

The study tests an oral probiotic called R-2487 to see if it is safe and well-tolerated in people with Sjögren's Syndrome. Researchers will monitor symptoms and check blood and stool samples for inflammation.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Open LabelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rise Therapeutics LLC

Lead Sponsor

Trials
5
Recruited
180+