Lactiplantibacillus Plantarum 299v Probiotic Probiotic Supplementation in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Central Macular Thickness
研究概览
简要总结
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:
- Does central macular thickness on optical coherence tomography decrease after 4 months of supplementation?
- Is visual acuity improved at 1, 2, 3, and 4 months following initiation of supplementation?
- 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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of at least 18 years, presence of DME at the current clinical visit
排除标准
- •Patients with contraindication to probiotic supplement (e.g. prior allergy or GI intolerance and any type of immunocompromised diseases).
研究组 & 干预措施
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.
干预措施: Lactobacillus plantarum 299v (Drug)
结局指标
主要结局
Central Macular Thickness
时间窗: 1,2,3,4-months following supplement initiation
Central macular thickness (CMT) on optical coherence tomography
次要结局
- Best corrected visual acuity(1, 2, 3, 4-months following supplement initiation)
- Anti-VEGF Frequency(At 1,2,3,4-months following supplement initiation)
研究者
Demetrios Vavvas
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
Massachusetts Eye and Ear Infirmary