This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1
University of Miami
Miami, Florida, United States
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.
Time frame: 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.
Time frame: month 3
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
Time frame: baseline, 1 week, 1 month, 3 months
Change in dry eye symptoms
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
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Pre-FMT, 1 Week, 1 Month, 3 months post FMT