Recruiting
Phase 2

Lactobacillus Plantarum 299v

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT07383701

Conditions

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lactobacillus plantarum 299v

Study Details

Brief 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

Diabetic Macular Edema

Study ID

NCT07383701

Start date

Jun 23, 2026

Status verified date

Sep, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Lactobacillus plantarum 299v

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Demetrios G. Vavvas, MD PhD

6175736874Demetrios_Vavvas@meei.harvard.edu

Locations

Mass Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Demetrios G. Vavvas, MD PhD

617-573-6874Demetrios_Vavvas@meei.harvard.edu

Principal Investigator:

Demetrios G. Vavvas, MD PhD

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • diabetic macular edema
  • Lactiplantibacillus plantarum 299v
  • probiotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.