NCT00224432已完成不适用
Double-Blind, Parallel, Randomised Study to Investigate the Clinical and Immunological Effects of Oral Administration of Probiotic Bacteria in Infants With Atopic Dermatitis With and Without Cow's Milk Allergy.
Groningen Research Institute for Asthma and COPD2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2001年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Significant decrease of SCORAD score in treated infants compared to placebo
研究概览
简要总结
To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.
详细描述
- To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA
- To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA
- To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants
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
入排标准
- 年龄范围
- 0 Years 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis
- •Suggestive of CMA (one additional symptom)
- •Scorad index (total) >20 at study entry
- •Below 5 months of age
- •Formula, not breast fed
- •Written informed consent from the parents
排除标准
- •• Previous or current use of anti-histamines, oral corticosteroids, probiotics
- •Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks
- •Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia)
- •Other GI disease with intestinal inflammation and/or increased intestinal permeability
- •Skin disorder, not atopic dermatitis
- •Participation in another clinical study
结局指标
主要结局
Significant decrease of SCORAD score in treated infants compared to placebo
次要结局
- IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells
- change in fecal TNF-α and α-1-antitrypsin, urinary EDN
- effect on faecal bacteria after probiotics
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy ChildrenAcute Upper Respiratory Tract Infections (Common Cold)NCT02640352Probi AB550
已完成
不适用
Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the ElderlySARS CoV-2 InfectionElderlyNCT04756466Biosearch S.A.201
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
Menopausal Symptoms Probiotic StudyMenopauseNCT06446869Community Pharmacology Services Ltd140
招募中
不适用
Investigation of the Use of a Probiotic Supplement in People With Long COVIDLong COVIDNCT05975034Sheffield Hallam University240