RECRUITING Phase 2 ClinicalTrials.gov

Lactiplantibacillus Plantarum 299v Probiotic Supplementation in Patients With Diabetic Macular Edema

Sponsor: Massachusetts Eye and Ear Infirmary • ClinicalTrials.gov ID: NCT07383701

Registry updated: 2026-09-30

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Description

This pilot prospective, interventional, longitudinal study, aims to evaluate the potential benefits of the probiotic supplement Lactobacillus plantarum 299v in patients with diabetic macular edema (DME). The study seeks to address the following questions: 1. Does central macular thickness on optical coherence tomography decrease after 4 months of supplementation? 2. Is visual acuity improved at 1, 2, 3, and 4 months following initiation of supplementation? 3. Is the number of anti-VEGF injections reduced following initiation of supplementation? Outcomes will be compared to a control group, using historic retrospective data. Participants will take Lactobacillus plantarum 299v orally twice daily for four months.

Interventions

Lactobacillus plantarum 299v (Drug)
Lactiplantibacillus Plantarum 299v Probiotic Supplementation, Twice Daily, for 4 Months

Eligibility criteria

Inclusion Criteria: * Age of at least 18 years, presence of DME at the current clinical visit Exclusion Criteria: * Patients with contraindication to probiotic supplement (e.g. prior allergy or GI intolerance and any type of immunocompromised diseases).

Conditions

Diabetic Macular Edema

Locations

Mass Eye and Ear — Boston, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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