The Effect of Probiotic Modulation of Enteral Dysbiosis on dIsease Activity in Patients With PSoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Effect on disease activity according to PASDAS categories
研究概览
简要总结
The main purpose of this study is to validate the positive effect of "Omnibiotic Stress Repair" on patients with active psoriatic Arthritis.
详细描述
This is a single center, double blind (patients and investigators), Placebo controlled randomized trial.
Consecutive patients with Psoriatic Arthritis (PsA) in moderate disease activity (Psoriatic Arthritis Disease Activity Score: PASDAS >3.2 - <5.4) on a stable treatment (no immunomodulatory treatment change in the last 3 months) with biological (bDMARDs) and/or synthetic disease modifying anti-rheumatic drugs (sDMARDs) and/or glucocorticoids will be included in the study. Clinical assessment will be scheduled at baseline, 12 weeks and 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient ≥18 years and <90 years of age
- •PsA according to CASPAR criteria
- •MoDA defined by a PASDAS >3.2 - <5.4
- •Stable immunomodulatory therapy for the last 12 weeks before baseline (no change in bDMARD/sDMARD/glucocorticoid treatment)
- •Written informed consent
排除标准
- •History of bariatric surgery
- •Prior use of probiotics in the last 24 weeks
- •Use of probiotics, other than the study product, during the study period.
- •Antibiotic therapy within the last 4 weeks before inclusion
- •Inflammatory bowel disease
- •Recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure
- •Recent (less than 12 weeks) stroke
- •Known malignancy
- •Inability of the patient to follow the treatment protocol
结局指标
主要结局
Effect on disease activity according to PASDAS categories
时间窗: 3 months
To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) after 3 months of intake of OBSR compared to placebo in PsA patients. Difference in response is defined by the different amount of patients shifting from moderate disease activity (PASDAS \> 3.2 - \< 5.4) to low disease activity or remission (PASDAS ≤ 3.2) in the two groups.
次要结局
- Effect on disease activity according to PASDAS score(3 and 6 months)
- Effect on disease activity according to PASDAS categories independent of concomitant medication(3 months)
- Longterm effect on disease activity according to PASDAS categories(3 and 6 months)
- Impact of disease according to the PSAID-12(3 and 6 months)
- Impact of disease according to the TJC(3 and 6 months)
- Impact of disease according to the SJC(3 and 6 months)
- Pain assessed by PtPain VAS(3 and 6 months)
- Enthesitis assessed by the LEI(3 and 6 months)
- Dactylitis assessed by the DS(3 and 6 months)
- Impact of disease according to the PGA(3 and 6 months)
- Impact of disease according to the EGA(3 and 6 months)
- Impact of disease according to the SF-36(3 and 6 months)
- Dietary assessment according to the Diet-Questionnaire(3 and 6 months)
- Skin involvement according to the PASI(3 and 6 months)
- Laboratory inflammation assessment according to CRP(3 and 6 months)
- Change in gut microbiota(3 and 6 months)
- Gut permeability according to Zonulin(3 and 6 months)
- Gut inflammation according to Calprotectin(3 and 6 months)
- Neutrophile function according to Phagocytosis assessment(3 and 6 months)
- Inflammation assessment according to cytokine Level(3 and 6 months)
- Lymphocyte subtypes according to FACS(3 and 6 months)
- Metabolic assessment using NMR(3 and 6 months)
- Impact of skin involvement according to the DLQI(3 and 6 months)
- Impact of disease according to the HAQ(3 and 6 months)
- Fatigue assessment accoring to the FACIT(3 and 6 months)
- Hospital anxietey and depression assessment according to the HADS(3 and 6 months)
- Laboratory inflammation assessment according to ESR(3 and 6 months)