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NCT03926286
Fecal Microbial Transplant (FMT) for Sjogrens Syndrome
Phase 1 trial testing FMP-30 in Sjogren's Syndrome in 10 participants. Completed in 1 June 2020.
1 June 2020
Quick facts
| Lead sponsor | University of Miami |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 15 April 2019 |
| Primary completion | 1 June 2020 |
| Estimated completion | 1 June 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- FMP-30 — full drug profile →
Conditions studied
- Sjogren's Syndrome — all drugs for Sjogren's Syndrome →
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):
-
Relationships Between Vitamin D, Gut Microbiome, and Systemic Autoimmunity.
Yamamoto EA, Jørgensen TN. · · 2019 · cited 151× · PMID 32038645 · DOI 10.3389/fimmu.2019.03141 -
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 -
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 -
Gut Dysbiosis and Fecal Microbiota Transplantation in Autoimmune Diseases.
Belvoncikova P, Maronek M, Gardlik R. · · 2022 · cited 61× · PMID 36142642 · DOI 10.3390/ijms231810729 -
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 -
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 -
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 -
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:
- PubMed search for NCT03926286
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other University of Miami trials
Trials by the same sponsor.
- NCT06003712 — Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI) · NA · not yet recruiting
- NCT06077071 — MRIdian "RADAR" Trial · NA · not yet recruiting
- NCT07472413 — Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project · Phase 3 · not yet recruiting
- NCT07322289 — Antibiotic-coated Braided Suture Study · NA · not yet recruiting
- NCT07469592 — eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03926286 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Miami
- Last refreshed: 5 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03926286.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing