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| Name | Class |
|---|---|
| Sjogrens Syndrome Foundation | UNKNOWN |
| Microbiome Health Research Institute | OTHER |
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This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT for Sjogrens | Experimental | FMT- active ingredient coming from participant's screening stool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMP-30 | Drug | FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with reported adverse events (AEs) and serious adverse events (SAEs) | 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. | 7 months |
| Number of participants with stable microbiome engraftment | 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. | month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dry eye symptoms | 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 | baseline, 1 week, 1 month, 3 months |
| Change in dry eye symptoms |
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Inclusion criteria:
Positive diagnosis of Sjogrens syndrome, defined by meeting two or more of the following three criteria:
Or by both of the following:
Positive antibodies to one of the early markers of Sjogrens Syndrome:
Age ≥ 18 years at time of enrollment
Able to provide signed and dated informed consent
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.
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.
Participant exclusion criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anat Galor, MD, MSPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33133 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29934134 | Background | Zaheer M, Wang C, Bian F, Yu Z, Hernandez H, de Souza RG, Simmons KT, Schady D, Swennes AG, Pflugfelder SC, Britton RA, de Paiva CS. Protective role of commensal bacteria in Sjogren Syndrome. J Autoimmun. 2018 Sep;93:45-56. doi: 10.1016/j.jaut.2018.06.004. Epub 2018 Jun 20. | |
| 29920643 | Background | De Luca F, Shoenfeld Y. The microbiome in autoimmune diseases. Clin Exp Immunol. 2019 Jan;195(1):74-85. doi: 10.1111/cei.13158. |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Dry eye symptoms will be measured by the Dry Eye Questionnaire 5 (DEQ5) Scale Range 0-22 Continuous with a higher number representing greater symptomatology of dry eye
| baseline, 1 week, 1 month, 3 months |
| Change in diversity of bacterial communities | 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. | Pre FMT, 3 months post FMT |
| Change in system immune profiles as measured by T cell populations | 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. | Pre-FMT, 1 Week, 1 Month, 3 months post FMT |
| Change in ocular and systemic symptoms as measured by the quality of life SF-12 Questionnaire | Ranges 0-100 with higher scores representing a better quality of life | Pre-FMT, 1 Week, 1 Month, 3 months post FMT |
| Change in self-reported ocular pain as assessed by the Numerical Rating Scale(NRS) | NRS Scoring Ranges from 0-10 with 0=no pain sensation and 10=the most intense eye pain imaginable | Pre-FMT, 1 Week, 1 Month, 3 months post FMT |
| Change in self-reported ocular pain as assessed by the Short-form McGill Pain Questionnaire(SFM-PQ) | SFM-PQ Scoring Ranges from 0-45 with zero to 45 with a higher score indicating more server eye pain | Pre-FMT, 1 Week, 1 Month, 3 months post FMT |
| Change in self-reported ocular pain as assessed by the Neuropathic Pain Symptom Inventory (NPSI) | NPSI Scoring Ranges from 0-100 with the higher score indicating the worse pain imaginable. | Pre-FMT, 1 Week, 1 Month, 3 months post FMT |
| Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 scoring Ranges from 0-27 with the higher score indicating a greater degree of depression | Pre-FMT, 1 Week, 1 Month, 3 months post FMT |
| Depression as assessed by the Symptom Checklist 90 for Depression (SCL-90 Depression) | SCL-90 Depression scoring ranges from 0-4 with the higher score indicating a greater degree of depression. | Pre-FMT, 1 Week, 1 Month, 3 months post FMT |
| Anxiety as assessed by the Symptom Checklist 90 for Anxiety (SCL-90 Anxiety) | SCL-90 Anxiety scoring ranges from 0-4 with the higher score indicating a greater degree of anxiety. | Pre-FMT, 1 Week, 1 Month, 3 months post FMT |
| 29438346 | Background | Wang C, Zaheer M, Bian F, Quach D, Swennes AG, Britton RA, Pflugfelder SC, de Paiva CS. Sjogren-Like Lacrimal Keratoconjunctivitis in Germ-Free Mice. Int J Mol Sci. 2018 Feb 13;19(2):565. doi: 10.3390/ijms19020565. |
| 27087247 | Background | de Paiva CS, Jones DB, Stern ME, Bian F, Moore QL, Corbiere S, Streckfus CF, Hutchinson DS, Ajami NJ, Petrosino JF, Pflugfelder SC. Altered Mucosal Microbiome Diversity and Disease Severity in Sjogren Syndrome. Sci Rep. 2016 Apr 18;6:23561. doi: 10.1038/srep23561. |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |