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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Mar 1, 2027 → Jun 1, 2027
See other at-risk trials from Massachusetts Eye and Ear Infirmary

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Recruitment opened Show 6 more changesShow less
    • Primary completion pushed from Mar 1, 2027 to Jun 1, 2027
    • Start date changed from estimate of Aug 1, 2026 to Jun 23, 2026
    • Site details revised
    • Publications: details revised at 3 of 3 entries
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 5 words
  2. Notable Start date: Mar 1, 2026 to Aug 1, 2026v3
  3. Minor Study description shortened, about 13 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07383701
Lead Sponsor Massachusetts Eye and Ear Infirmary
Conditions
(from sponsor)
Diabetic Macular Edema
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov