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

NCT07383701 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2025P001157
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.Does central macular thickness on optical coherence tomography decrease after 4 months of supplementation?
2. 2.Is visual acuity improved at 1, 2, 3, and 4 months following initiation of supplementation?
3. 3.Is the number of anti-VEGF injections reduced following initiation of supplementation?

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edema; Lactiplantibacillus plantarum 299v; probiotic

Outcome Measures

Primary Outcomes (1)

• Central Macular Thickness

  Central macular thickness (CMT) on optical coherence tomography

  1,2,3,4-months following supplement initiation

Secondary Outcomes (2)

• Best corrected visual acuity

  1, 2, 3, 4-months following supplement initiation

• Anti-VEGF Frequency

  At 1,2,3,4-months following supplement initiation

Study Arms (1)

Main Arm - twice daily for 4 months

EXPERIMENTAL

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

Drug: Lactobacillus plantarum 299v

Interventions

Lactobacillus plantarum 299v DRUG

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

Main Arm - twice daily for 4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of at least 18 years, presence of DME at the current clinical visit

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Mass Eye and Ear

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Senger DR, Li D, Jaminet SC, Cao S. Activation of the Nrf2 Cell Defense Pathway by Ancient Foods: Disease Prevention by Important Molecules and Microbes Lost from the Modern Western Diet. PLoS One. 2016 Feb 17;11(2):e0148042. doi: 10.1371/journal.pone.0148042. eCollection 2016.

  PMID: 26885667 RESULT

• Kensler TW, Wakabayashi N, Biswal S. Cell survival responses to environmental stresses via the Keap1-Nrf2-ARE pathway. Annu Rev Pharmacol Toxicol. 2007;47:89-116. doi: 10.1146/annurev.pharmtox.46.120604.141046.

  PMID: 16968214 RESULT

• Li JQ, Welchowski T, Schmid M, Letow J, Wolpers C, Pascual-Camps I, Holz FG, Finger RP. Prevalence, incidence and future projection of diabetic eye disease in Europe: a systematic review and meta-analysis. Eur J Epidemiol. 2020 Jan;35(1):11-23. doi: 10.1007/s10654-019-00560-z. Epub 2019 Sep 12.

  PMID: 31515657 RESULT

Central Study Contacts

Demetrios G. Vavvas, MD PhD

CONTACT

6175736874; Demetrios_Vavvas@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Solman and Libe Friedman Professor of Ophthalmology Director Retina Service Mass. Eye and Ear / Mass General Hospital Co-Director Ocular Regenerative Medical Institute Harvard Medical School

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)