drugset / Trial / NCT07383701

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

NCT07383701

Phase 2 Not yet recruiting 36 enrolled Massachusetts Eye and Ear Infirmary
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-08-01
Primary completion
2027-03-01
Completion
2027-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus plantarum 299v Other / unclassified Oral