Lactiplantibacillus Plantarum 299v Probiotic Supplementation in Patients With Diabetic Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactobacillus plantarum 299v.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lactiplantibacillus Plantarum 299v Probiotic Probiotic Supplementation in Patients With Diabetic Macular Edema
Overview
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.
Detailed description
Study Design: Prospective open label longitudinal interventional study with oral probiotic supplement Lactobacillus plantarum.
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).
Eligible individuals (patients at least 18 years old with diabetic macular
Participants: Patients with DME that belong in the following two groups:
* Group A: 12 Patients with mild DME and good visual acuity (\<= 20/30) similar to DRCR network protocol V that do not need anti-VEGF injections as per standard clinical care. * Group B: 12 Patients with DME that need anti-VEGF injections as per standard clinical care.
Intervention: Oral probiotic supplement L. plantarum 299v twice daily for 4 months for both groups.
Study outcomes:
* OCT with central macular thickness (CMT) at 1, 2, 3, 4-months follow-up. * Visual Acuity at 1, 2, 3, 4-months follow-up. * Number of anti VEGF injections.
In group A, the percentage of patients with a stability or improvement in DME as determined by a stability (+/- 9% of OCT CMT) or a reduction of DME (\>= 30 microns or \>= 10% decrease of CMT) from baseline will be measured. Secondary endpoints will be visual acuity and need for injection initiation during the 4 months.
In group B, the same outcomes as in group A will be measured. Furthermore, the number of injections group A over the course of 4 months will be evaluated.
Data from both groups will be compared to historical data available at the study site.
Interventions
- Drug Lactobacillus plantarum 299v
Lactiplantibacillus Plantarum 299v Probiotic Supplementation, Twice Daily, for 4 Months
Primary outcome measures
- Central Macular Thickness [Time frame: 1,2,3,4-months following supplement initiation]
Secondary outcome measures (2)
- Best corrected visual acuity [Time frame: 1, 2, 3, 4-months following supplement initiation]
- Anti-VEGF Frequency [Time frame: At 1,2,3,4-months following supplement initiation]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mass Eye and Ear — Boston
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07383701 · 2025P001157