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

NCT07383701 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lactobacillus plantarum 299v

Lactiplantibacillus Plantarum 299v Probiotic Supplementation, Twice Daily, for 4 Months

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-03-01
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07383701 on ClinicalTrials.gov