Clinical trial: Fecal Microbial Transplant (FMT) for Sjogrens Syndrome (NCT03926286)

Eligibility criteria:
Inclusion criteria:

          1. Positive diagnosis of Sjogrens syndrome, defined by meeting two or more of the
             following three criteria:

               -  Positive serum anti-SS-A/Ro and/or anti-SS-B/La (or positive rheumatoid factor
                  and ANA ≥ 1:320)

               -  Labial salivary gland biopsy exhibiting focal lymphocytic sialadenitis with a
                  focus score ≥ focus/4 mm2

               -  Keratoconjunctivitis sicca with ocular staining score ≥ 3 (assuming that
                  individual is not currently using daily eye drops for glaucoma, and has not had
                  corneal surgery or cosmetic eyelid surgery in the last 5 years)

             Or by both of the following:

             Positive antibodies to one of the early markers of Sjogrens Syndrome:

               -  Anti-salivary gland protein 1 (SP1)

               -  Anti-carbonic anhydrase 6 (CA6)

               -  Parotid secretory protein (PSP) Ocular staining score ≥ 3

          2. Age ≥ 18 years at time of enrollment

          3. Able to provide signed and dated informed consent

          4. Women of child childbearing potential in sexual relationships with men must use an
             acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks
             after completing study treatment.

          5. Males must agree to avoid impregnation of women during and for four weeks after
             completing study treatment through use of an acceptable method of contraception*.

               -  Includes, but is not limited to, barrier with additional spermicidal foam or
                  jelly, intrauterine device, hormonal contraception (started at least 30 days
                  prior to study enrollment), intercourse with men who underwent vasectomy.

                    -  Includes, but is not limited to, barrier with additional spermicidal foam or
                       jelly and vasectomy.

        Participant exclusion criteria

        Exclusion Criteria:

          1. Inability to provide informed consent and/or unable or unwilling to comply with
             protocol requirements.

          2. Antibiotics for at least 2 weeks prior to FMT.

          3. Active infection for >15 days: bacteremia, urinary tract infection, pneumonia or
             abdominal collection.

          4. Known or suspected toxic megacolon and/or known small bowel ileus.

          5. Previous FMT

          6. Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months
             before enrollment. This does not include appendectomy or cholecystectomy.

          7. History of total colectomy or bariatric surgery.

          8. Antibiotics for the treatment of an active infection or anticipated antibiotic use
             during trial duration.

          9. Concurrent intensive induction chemotherapy, radiation therapy or biological treatment
             for active malignancy.

         10. Expected life expectancy < 6 months

         11. Patients with a history of severe anaphylactic or anaphylactoid food allergy.

         12. Solid organ transplant patients ≤ 90 days post-transplant or on active treatment for
             rejection.

         13. Neutropenia (<500 neutrophils/mL) or other severe immunosuppression. Patients on
             monoclonal antibodies to B and T cells, anti-tumor necrosis factor, glucocorticoids,
             antimetabolites, calcineurin inhibitors may be enrolled after consultation with their
             medical doctor.

         14. Renal failure (GFR <30 or dialysis)

         15. Human immunodeficiency virus+ controlled or not well controlled on antiretroviral
             therapy

         16. Regular probiotic supplement use within prior 2 weeks to enrollment

         17. Pregnancy or inability/unwillingness to use contraceptives.

         18. A condition that would jeopardize the safety or rights of the subject, would make it
             unlikely for the subject to complete the study, or would confound the results of the
             study.

         19. Exclusion on the discretion of the PI.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment