Lactiplantibacillus Plantarum 299v Probiotic Supplementation in Patients With Diabetic Macular Edema
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lactobacillus plantarum 299v.
- Кому может быть актуально
- Состояния в реестре: Diabetic Macular Edema. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Lactiplantibacillus Plantarum 299v Probiotic Probiotic Supplementation in Patients With Diabetic Macular Edema
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Lactobacillus plantarum 299v
Lactiplantibacillus Plantarum 299v Probiotic Supplementation, Twice Daily, for 4 Months
Первичные конечные точки
- Central Macular Thickness [Срок оценки: 1,2,3,4-months following supplement initiation]
Вторичные конечные точки (2)
- Best corrected visual acuity [Срок оценки: 1, 2, 3, 4-months following supplement initiation]
- Anti-VEGF Frequency [Срок оценки: At 1,2,3,4-months following supplement initiation]
Критерии участия
Критерии включения
- Age of at least 18 years, presence of DME at the current clinical visit
Критерии исключения
- Patients with contraindication to probiotic supplement (e.g. prior allergy or GI intolerance and any type of immunocompromised diseases).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Mass Eye and Ear — Boston
Публикации
- 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
Идентификаторы
NCT: NCT07383701 · 2025P001157