Fecal Microbial Transplant (FMT) for Sjogrens Syndrome
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|ClinicalTrials.gov Identifier: NCT03926286|
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : June 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sjogren's Syndrome||Drug: FMP-30||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbial Transplant for Sjogrens Syndrome|
|Actual Study Start Date :||April 15, 2019|
|Actual Primary Completion Date :||June 1, 2020|
|Actual Study Completion Date :||June 1, 2020|
Experimental: FMT for Sjogrens
FMT- active ingredient coming from participant's screening stool
FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1
- Number of participants with reported adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 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 [ Time Frame: 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.
- Change in dry eye symptoms [ Time Frame: 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
- Change in dry eye symptoms [ Time Frame: baseline, 1 week, 1 month, 3 months ]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
- Change in diversity of bacterial communities [ Time Frame: 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 [ Time Frame: 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 ocular and systemic symptoms as measured by the quality of life SF-12 Questionnaire [ Time Frame: Pre-FMT, 1 Week, 1 Month, 3 months post FMT ]Ranges 0-100 with higher scores representing a better quality of life
- Change in self-reported ocular pain as assessed by the Numerical Rating Scale(NRS) [ Time Frame: 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) [ Time Frame: 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 self-reported ocular pain as assessed by the Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: 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.
- Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926286
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33133|
|Principal Investigator:||Anat Galor, MD, MSPH||University of Miami|