Sjogren's Syndrome
Conditions
Keywords
Dry Eye, Auto-Immune Disorder
Brief summary
This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.
Interventions
DRUGFMP-30
FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1
Sponsors
Sjogrens Syndrome Foundation
Microbiome Health Research Institute
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with reported adverse events (AEs) and serious adverse events (SAEs) | 7 months | As an evaluation of the safety of FMT, the number of participants with reported AEs and SAEs will be collected. All occurrences of AEs and SAEs, regardless of relatedness to FMT, will be reported and assessed by the clinician using the NIH CTCAE. |
| Number of participants with stable microbiome engraftment | month 3 | Engraftment will be analyzed via the Jensen-Shannon divergence (JSD). The engraftment scores will be the ratio between the donors and recipients at the bacterial genus level. Participants who successfully engraft will more closely resemble the donor microbial profile on JSD analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in diversity of bacterial communities | Pre FMT, 3 months post FMT | This will be captured via high-throughput 16S gene sequencing using DNA extracted from stool specimens in study participants. The Shannon diversity index will be used as our primary measure of diversity. |
| Change in system immune profiles as measured by T cell populations | Pre-FMT, 1 Week, 1 Month, 3 months post FMT | System immune profiles will be evaluated by completing a comprehensive immuno-phenotypic profile from blood samples evaluating T cell populations including Th1, Th17, and T regulatory cells. |
| Change in self-reported ocular pain as assessed by the Numerical Rating Scale(NRS) | Pre-FMT, 1 Week, 1 Month, 3 months post FMT | NRS Scoring Ranges from 0-10 with 0=no pain sensation and 10=the most intense eye pain imaginable |
| Change in self-reported ocular pain as assessed by the Short-form McGill Pain Questionnaire(SFM-PQ) | Pre-FMT, 1 Week, 1 Month, 3 months post FMT | SFM-PQ Scoring Ranges from 0-45 with zero to 45 with a higher score indicating more server eye pain |
| Change in ocular and systemic symptoms as measured by the quality of life SF-12 Questionnaire | Pre-FMT, 1 Week, 1 Month, 3 months post FMT | Ranges 0-100 with higher scores representing a better quality of life |
| Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) | Pre-FMT, 1 Week, 1 Month, 3 months post FMT | PHQ-9 scoring Ranges from 0-27 with the higher score indicating a greater degree of depression |
| Depression as assessed by the Symptom Checklist 90 for Depression (SCL-90 Depression) | Pre-FMT, 1 Week, 1 Month, 3 months post FMT | SCL-90 Depression scoring ranges from 0-4 with the higher score indicating a greater degree of depression. |
| Anxiety as assessed by the Symptom Checklist 90 for Anxiety (SCL-90 Anxiety) | Pre-FMT, 1 Week, 1 Month, 3 months post FMT | SCL-90 Anxiety scoring ranges from 0-4 with the higher score indicating a greater degree of anxiety. |
| Change in self-reported ocular pain as assessed by the Neuropathic Pain Symptom Inventory (NPSI) | Pre-FMT, 1 Week, 1 Month, 3 months post FMT | NPSI Scoring Ranges from 0-100 with the higher score indicating the worse pain imaginable. |
| Change in dry eye symptoms | baseline, 1 week, 1 month, 3 months | Dry eye symptoms will be measured by the Ocular Surface Disease Index (OSDI) Scale 0-100 Continuous with higher scores representing greater dry eye symptoms |
Countries
United States
Outcome results
None listed