Efficacy of Probiotic Therapy on Disease Outcomes in HLA-B27 Associated Anterior Uveitis
试验速览
- 阶段
- 不适用
- 状态
- Other
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- a.To demonstrate that concurrent probiotic therapy during standard treatment for HLA-B27 associated AU facilitates faster remission of clinical inflammation.
研究概览
简要总结
Uveitis or intraocular inflammation isthe fifth most common cause of blindness and the association of Anterior Uveitis (AU)with a Human Leucocyte Antigen (HLA) allele, called HLA-B27 is the mostfrequent etiology.Typically, it presents as recurrent attacks of acute, unilateral,non-granulomatous AU, that is treated with corticosteroid and cycloplegic eye drops. The exact mechanism by which HLA-B27antigen predisposes to inflammation is not clear. However, recent research has implicated the gut microbiome in the development of HLA-B27 associated AU. In addition, our earlier work on the gutmicrobiome in uveitis patients (autoimmune and idiopathic), revealed thatcompared to healthy controls, uveitis patients have reduced diversity andabundance of anti-inflammatory, probiotic and antibacterial organisms in thegut. Together, this highlights the potential of manipulating the microbiome toalter the frequency and intensity of the disease.
The proposed study aims to evaluatethe efficacy of probiotic therapy in modifying disease outcomes in HLA-B27anterior uveitis. The study drug “Provinorm†(UNIQUEBIOTECH,Hyderabad, India) is a commercially available probiotic that contains a combinationof Lactobacillus acidophilus (2billion cfu), L. rhamnosus (2 billioncfu), L. plantarum (1. 0 billioncfu), L. caseii (1 billion cfu), L. reuteri (2 billion cfu), L. fermentum (2 billion cfu), Bifidobacteriumbifdum (1 billion cfu)and fructo-oligosaccharides (100 mg). Provinorm was observed to be effective in minimizingthe vaginal infections and consequent symptoms in patients withBacterial Vaginosis. In the present study, the intake of probiotic isexpected to fasten the remission of clinical inflammation of AU, decrease thenumber of relapses and also reduce the secretion of pro-inflammatory cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Ability to give informed consent for participation.
- •2.Males or females greater than or equal to 18 years of age.
- •3.Patients and controls should not have received antibiotics, pro- or prebiotic treatment for at least three months prior to sample collection.
- •4.Patients with Non-granulomatous anterior uveitis.
- •5.Presenting AC reaction greater than or equal to grade
- •6.Onset less than or equal to 2 weeks.
- •7.HLA-B27 positive 8.All cohorts are matched for diet, age, gender, ethnicity etc.
- •9.Rule out infectious etiology.
排除标准
- •1.Posterior segment inflammation more than spillover vitritis.
- •2.Active infectious uveitis 3.Lens induced uveitis 4.Non-HLA-B27 associated uveitis 5.Any significant systemic or ocular disease that could compromise the uveitis in the study eye.
- •These include, but are not limited to: a.Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR).
- •b.Wet age-related macular degeneration.
- •c.Myopic degeneration with active sub-foveal choroidal neovascularization.
- •d.Uncontrolled glaucoma, intraocular pressure of > 21 mm Hg while on medical therapy, or chronic hypotony (<6 mm Hg).
- •6.Any implantable corticosteroid-eluting device (e.g. Ozurdex, I-vation, triamcinolone acetonide [TA] intravitreal implant) in the study eye within the past 90 days.
- •7.Any of the following treatments within 90 days prior to enrollments: a.Intravitreal injections (including steroids and anti-vascular endothelial growth factors); b.Posterior subtenon steroids.
- •8.Free from antibiotic and systemic immunosuppressant use (three months prior to presentation and during the course of study).
结局指标
主要结局
a.To demonstrate that concurrent probiotic therapy during standard treatment for HLA-B27 associated AU facilitates faster remission of clinical inflammation.
时间窗: 1 Week, 4 Weeks, 8 weeks
b.To demonstrate that probiotic therapy helps in prevention of relapse in patients with quiescent HLA-B27 associated AU.
时间窗: 1 Week, 4 Weeks, 8 weeks
次要结局
- To monitor pro-inflammatory cytokines in serum of patients prior to and after probiotic therapy(1 Week, 4 Weeks, 8 weeks)