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Fecal Microbial Transplant (FMT) for Sjogrens Syndrome

NCT03926286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-06-05

No results posted yet for this study

Summary

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

Conditions

  • Sjogren's Syndrome

Interventions

DRUG

FMP-30

FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1

Sponsors & Collaborators

  • Sjogrens Syndrome Foundation

    collaborator UNKNOWN

  • Microbiome Health Research Institute

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Anat Galor, MD, MSPH · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2020-06-01
Completion
2020-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03926286 on ClinicalTrials.gov