Health TrialsbyHealthPanel

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

ConditionDiabetic Macular Edema
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts Eye and Ear Infirmary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Lactobacillus plantarum 299v

    Drug

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

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Main Arm - twice daily for 4 monthsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Central Macular Thickness

Central macular thickness (CMT) on optical coherence tomography

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

Secondary outcomes

1

Best corrected visual acuity

Best corrected visual acuity

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

Anti-VEGF Frequency

Number of anti VEGF injections

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Eye and Ear Infirmary

Lead sponsor

Source ClinicalTrials.gov
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