Probiotic Supplementation for Diabetic Macular Edema

Overseen By Demetrios G. Vavvas, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Immunocompromised diseases, allergy, GI intolerance

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

In this pilot prospective, interventional, longitudinal study, we aim 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.

Are You a Good Fit for This Trial?

This trial is for patients with diabetic macular edema, a condition affecting the eye. Participants will be those who can safely consume probiotics and are willing to take Lactobacillus plantarum 299v twice daily for four months. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I have diabetic macular edema now.

I am 18 years old or older.

Exclusion Criteria

Patients with contraindication to probiotic supplement (e.g. prior allergy or GI intolerance and any type of immunocompromised diseases)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lactobacillus plantarum 299v orally twice daily for four months

16 weeks

Monthly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lactiplantibacillus Plantarum 299v

Trial Overview

The study tests if the probiotic Lactobacillus plantarum 299v can reduce thickness in the central part of the retina and improve vision over four months compared to past data from patients who didn't receive this supplement.

How Is the Trial Designed?

Group I: Main Arm - twice daily for 4 months Experimental Treatment 1 Intervention

This is the only arm in this study. All participants will receive 4 months of Lactobacillus plantarum supplementation.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+