NCT03822624Unknown不适用
Randomized, Double Blind, Placebo Controlled Study to Evaluate Efficiency and Safety on the Use of a Probiotic in SCORAD Reduction in 4-to-17 Years-old Patients With Atopic Dermatitis
Biopolis S.L.6 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年5月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Change from baseline in the SCORAD index at 12 weeks.
研究概览
简要总结
The study's objective is to confirm that an oral probiotic treatment reduces the signs and symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 4 to 17 years, as compared to placebo. It will also be examined if the probiotic treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares, and increases the time till the first disease flare after the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 4 to 17 years, both inclusive.
- •Diagnosed with atopic dermatitis according to Hanifin and Rajka criteria.
- •SCORAD index of 20-40, both inclusive.
- •Patients whose parents or legal guardian sign the informed consent.
- •The minor over 12 years must also give their consent to participate in the trial.
排除标准
- •Pregnancy.
- •Breast feeding.
- •Women of childbearing age who, in the opinion of the investigator, do not commit to using an effective method of contraception, if they have an active sex life or start during the trial.
- •Treated with phototherapy for the atopic dermatitis in the previous 2 months.
- •Treated with systemic corticosteroids in the previous 2 months or need for corticosteroids anticipated during the first 12 weeks of the study.
- •Having undergone cytotoxic or immunosuppressive therapy in the previous 2 months or having an anticipated need for cytotoxic or immunosuppressive therapy during the first 12 weeks of the study.
- •Treated with probiotics in the previous two months.
- •Treated with systemic antibiotics in the previous four days.
- •Patients with a fever (temperature > 37.5°C, axillary or equivalent).
- •Serious allergic diseases.
- •Diseases related to immunodeficiency processes or cancer.
- •Other skin diseases that can make assessment of the atopic dermatitis difficult or which require the continuous use of topical corticosteroids.
- •Patients in whom any of the study products is contraindicated according to its summary of product characteristics.
- •Patients who have participated in research studies with medicinal products during the previous 3 months.
- •Patients with gluten or lactose intolerance or inflammatory bowel disease (Crohn's disease or ulcerative colitis).
研究组 & 干预措施
Probiotic group
Experimental
干预措施: Probiotic (Dietary Supplement)
Placebo group
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in the SCORAD index at 12 weeks.
时间窗: 12-week
SCORAD: SCOring of Atopic Dermatitis Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
次要结局
- Use of antihistamines and other treatments.(12-week)
- Disease-free time up to 24 weeks.(24-week)
- Number of days that each patient requires the administration of topical corticosteroids in disease flares.(12-week)
- Adherence to the treatment.(12-week)
- Total dose of topical corticosteroids.(12-week)
- Number of days that each patient requires the administration of topical corticosteroids.(12-week)
- Number of patients who reach a CGI score lower than 2.(12-week)
- Number of adverse events.(12-week)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
The Efficacy of Probiotics as an Adjunct to Treatment of SIBO With RifaximinIrritable Bowel SyndromeSmall Intestinal Bacterial OvergrowthSIBONCT06223685Pomeranian Medical University Szczecin129
已完成
不适用
Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young PatientsDermatitis, AtopicNCT02585986Biopolis S.L.51
招募中
不适用
Synbiotic to Attenuate Resorption of the SkeletonInflammationAgingOsteoporosisNCT06389539Hebrew SeniorLife220
已完成
不适用
The Efficacy on Overweight With Oral Supplemenation of Probiotics and PrebioticsOverweightNCT05710055Shenzhen Precision Health Food Technology Co. Ltd.,200
已完成
不适用
The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy AdultsGastrointestinal HealthImmune HealthDigestive HealthNCT05595980BIO-CAT Microbials, LLC80