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NCT03926286

Fecal Microbial Transplant (FMT) for Sjogrens Syndrome

Completed Phase 1 Last updated 5 June 2020
What this trial tests

Phase 1 trial testing FMP-30 in Sjogren's Syndrome in 10 participants. Completed in 1 June 2020.

Timeline
15 April 2019
Primary endpoint
1 June 2020
1 June 2020

Quick facts

Lead sponsorUniversity of Miami
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date15 April 2019
Primary completion1 June 2020
Estimated completion1 June 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Miami

Who can join

18 and older, any sex, with Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Relationships Between Vitamin D, Gut Microbiome, and Systemic Autoimmunity.
    Yamamoto EA, Jørgensen TN. · · 2019 · cited 151× · PMID 32038645 · DOI 10.3389/fimmu.2019.03141
  2. Fecal microbiota transplantation beyond Clostridioides difficile infections.
    Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
  3. The gut-eye-lacrimal gland-microbiome axis in Sjögren Syndrome.
    Trujillo-Vargas CM, Schaefer L, Alam J, Pflugfelder SC, et al · · 2020 · cited 71× · PMID 31644955 · DOI 10.1016/j.jtos.2019.10.006
  4. Gut Dysbiosis and Fecal Microbiota Transplantation in Autoimmune Diseases.
    Belvoncikova P, Maronek M, Gardlik R. · · 2022 · cited 61× · PMID 36142642 · DOI 10.3390/ijms231810729
  5. Autoimmunity in dry eye disease - An updated review of evidence on effector and memory Th17 cells in disease pathogenicity.
    Chen Y, Dana R. · · 2021 · cited 55× · PMID 34509656 · DOI 10.1016/j.autrev.2021.102933
  6. Dry eye syndrome: comprehensive etiologies and recent clinical trials.
    Huang R, Su C, Fang L, Lu J, et al · · 2022 · cited 52× · PMID 35678897 · DOI 10.1007/s10792-022-02320-7
  7. Fecal Microbial Transplant in Individuals With Immune-Mediated Dry Eye.
    Watane A, Cavuoto KM, Rojas M, Dermer H, et al · · 2022 · cited 49× · PMID 34214453 · DOI 10.1016/j.ajo.2021.06.022
  8. The role of the microbiome in gastrointestinal inflammation.
    Sanders DJ, Inniss S, Sebepos-Rogers G, Rahman FZ, et al · · 2021 · cited 41× · PMID 34076695 · DOI 10.1042/bsr20203850

Verify or expand the search:

Other recruiting trials for Sjogren's Syndrome

Currently open trials in the same condition.

Other University of Miami trials

Trials by the same sponsor.

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Data sources for this page

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