Fecal Microbial Transplant in Individuals with Immune-mediated Dry Eye.

Abstract

OBJECTIVE\nTo evaluate the safety of Fecal Microbial Transplant (FMT) in individuals with immune-mediated dry eye (DE).\n\n\nDESIGN\nOpen-label, non-randomized clinical trial.\n\n\nSTUDY POPULATION\nTen individuals with DE symptoms and signs meeting criteria for Sjögren s or positive early Sjögren s markers.\n\n\nPROCEDURES\nTwo FMTs from a single healthy donor were delivered via enema, one week apart.\n\n\nMAIN OUTCOME MEASURES\nThe 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.\n\n\nRESULTS\nMean 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 (Th1: r=0.76, p=0.01; Th17: 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.\n\n\nCONCLUSIONS\nFMT 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.