Fecal Microbial Transplant (FMT) for Sjogrens Syndrome

University of Miami

Status and phase: Completed; Phase 1

Conditions: Sjogren's Syndrome

Treatments: Drug: FMP-30

Study type: Interventional

Funder types: Other

Identifiers

NCT03926286

20170733

Details and patient eligibility

About

This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

FMT for Sjogrens

Experimental group

Description:

FMT- active ingredient coming from participant's screening stool

Treatment:

Drug: FMP-30