Lactobacillus plantarum 299v Probiotic for Diabetic Macular Edema
Official title: Lactiplantibacillus Plantarum 299v Probiotic Probiotic Supplementation in Patients With Diabetic Macular Edema
Run by Massachusetts Eye and Ear Infirmary · NCT07383701 · Data updated 2026-11-12
A probiotic pill taken twice daily for four months is tested to see if it can help people with diabetic macular edema see better or need fewer eye injections.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | June 23, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07383701 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with diabetic macular edema, including those not currently needing anti-VEGF injections and those who do need injections per standard care.
✕Probably not a fit
Patients with contraindications to probiotics, immunocompromised individuals, or those unlikely to respond based on baseline disease.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, prospective, open-label study testing Lactobacillus plantarum 299v as an oral supplement for adults with diabetic macular edema. Participants in two groups receive the probiotic for four months and undergo eye imaging and vision testing at 1–4 months, with tracking of anti-VEGF injections. Outcomes compare changes in central macular thickness and visual acuity to historical data. The study evaluates whether the probiotic could reduce treatment burden or improve eye structure and function. Eligibility includes adults with DME, while contraindications include probiotic intolerance or immunocompromised status.
Why it matters
Potential benefit: If successful, the probiotic could help stabilize or improve macular edema and potentially reduce the need for injections.
How similar studies have gone: Prior work has explored microbiome-related approaches in ocular diseases, but this exact probiotic strategy for DME is exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Mass Eye and Ear
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Demetrios G. Vavvas, MD PhD
- Email: Demetrios_Vavvas@meei.harvard.edu
- Phone: 6175736874
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.