Fecal Microbial Transplant (FMT) for Sjogrens Syndrome
- Conditions
- Sjogren's Syndrome
- Interventions
- Drug: FMP-30
- Registration Number
- NCT03926286
- Lead Sponsor
- University of Miami
- Brief Summary
This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
- Inability to provide informed consent and/or unable or unwilling to comply with protocol requirements.
- Antibiotics for at least 2 weeks prior to FMT.
- Active infection for >15 days: bacteremia, urinary tract infection, pneumonia or abdominal collection.
- Known or suspected toxic megacolon and/or known small bowel ileus.
- Previous FMT
- Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
- History of total colectomy or bariatric surgery.
- Antibiotics for the treatment of an active infection or anticipated antibiotic use during trial duration.
- Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy.
- Expected life expectancy < 6 months
- Patients with a history of severe anaphylactic or anaphylactoid food allergy.
- Solid organ transplant patients ≤ 90 days post-transplant or on active treatment for rejection.
- 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.
- Renal failure (GFR <30 or dialysis)
- Human immunodeficiency virus+ controlled or not well controlled on antiretroviral therapy
- Regular probiotic supplement use within prior 2 weeks to enrollment
- Pregnancy or inability/unwillingness to use contraceptives.
- 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.
- Exclusion on the discretion of the PI.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMT for Sjogrens FMP-30 FMT- active ingredient coming from participant's screening stool
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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.
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.
Change in dry eye symptoms 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 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
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
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States