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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT07383701
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lactobacillus plantarum 299v — DRUG
    Lactiplantibacillus Plantarum 299v Probiotic Supplementation, Twice Daily, for 4 Months

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Mar 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Main Arm - twice daily for 4 months
    This is the only arm in this study. All participants will receive 4 months of Lactobacillus plantarum supplementation.

Primary Outcome Measure

Central Macular Thickness [ Time Frame: 1,2,3,4-months following supplement initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass Eye and EarBostonMassachusetts02114
Demetrios G. Vavvas, MD PhD
[email protected]
617-573-6874
Demetrios G. Vavvas, MD PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Mass Eye and Ear· Boston, MA

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