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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
Sponsor:
Collaborators:
Sjogrens Syndrome Foundation
Microbiome Health Research Institute
Information provided by (Responsible Party):
Anat Galor, University of Miami

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date June 5, 2020
Actual Study Start Date  ICMJE April 15, 2019
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbial Transplant (FMT) for Sjogrens Syndrome
Official Title  ICMJE Fecal Microbial Transplant for Sjogrens Syndrome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sjogren's Syndrome
Intervention  ICMJE Drug: FMP-30
FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1
Study Arms  ICMJE Experimental: FMT for Sjogrens
FMT- active ingredient coming from participant's screening stool
Intervention: Drug: FMP-30
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 exclusion criteria

Exclusion Criteria:

  1. Inability to provide informed consent and/or unable or unwilling to comply with protocol requirements.
  2. Antibiotics for at least 2 weeks prior to FMT.
  3. Active infection for >15 days: bacteremia, urinary tract infection, pneumonia or abdominal collection.
  4. Known or suspected toxic megacolon and/or known small bowel ileus.
  5. Previous FMT
  6. Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
  7. History of total colectomy or bariatric surgery.
  8. Antibiotics for the treatment of an active infection or anticipated antibiotic use during trial duration.
  9. Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy.
  10. Expected life expectancy < 6 months
  11. Patients with a history of severe anaphylactic or anaphylactoid food allergy.
  12. Solid organ transplant patients ≤ 90 days post-transplant or on active treatment for rejection.
  13. 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.
  14. Renal failure (GFR <30 or dialysis)
  15. Human immunodeficiency virus+ controlled or not well controlled on antiretroviral therapy
  16. Regular probiotic supplement use within prior 2 weeks to enrollment
  17. Pregnancy or inability/unwillingness to use contraceptives.
  18. 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.
  19. Exclusion on the discretion of the PI.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926286
Other Study ID Numbers  ICMJE 20170733
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anat Galor, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE
  • Sjogrens Syndrome Foundation
  • Microbiome Health Research Institute
Investigators  ICMJE
Principal Investigator: Anat Galor, MD, MSPH University of Miami
PRS Account University of Miami
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP