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

RecruitingPhase 2Ages 18 Years - anyAllMassachusetts Eye and Ear Infirmary
NCT07383701 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Lactobacillus plantarum 299v
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Where

1 site
Mass Eye and Ear
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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