To evaluate the safety of Fecal Microbial Transplant (FMT) in individuals with immune-mediated dry eye (DE).
Open-label, non-randomized clinical trial.
Ten individuals with DE symptoms and signs meeting criteria for Sjögren’s or positive early Sjögren’s markers.
Two FMTs from a single healthy donor were delivered via enema, one week apart.
The primary outcome was safety. In addition, gut microbiome profiles, DE metrics, and T cell profiles in blood were examined at baseline before FMT, and at 1 week, 1 month, and 3 months after FMT.
Mean age of the population was 60.4 years; 30% were male, 50% were white, and 50% were Hispanic. At baseline, all subjects had significantly different gut microbiome profiles compared to the donor including higher mean diversity indices. Subjects had a decreased abundance of genera Faecalibacterium, Prevotella, and Ruminococcus and an increased abundance of genera Alistipes, Streptococcus, and Blautia compared to the donor. Effector and regulatory T cell profiles were positively correlated with each other and with DE symptom severity (Th: r=0.76, p=0.01; Th: r=0.83, p=0.003; CD25: r=0.66, p=0.04; FoxP3: r=0.68, p=0.03). No adverse events were noted with FMT. After FMT, gut microbiome profiles in 8 subjects moved closer to the donor’s profile. As a group, gut microbiome profiles at all follow-up time points were more similar to the original recipients’ than the donor’s microbiome, however certain phyla, classes, and genera OTU numbers remained closer to the donor versus recipients’ baseline profiles out to 3 months. Five individuals subjectively reported improved dry eye symptoms 3 months after FMT.
FMT was safely performed in individuals with immune-mediated DE, with certain bacterial profiles resembling the donor out to 3 months after FMT. Half the subjects reported improved DE symptoms. The most effective FMT administration method is yet to be determined.

Copyright © 2021. Published by Elsevier Inc.