此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

The Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis

2008年4月10日 更新者:University of Jena

Intervention Study on the Effects of a Probiotic Yoghurt Drink on the Immune System and Further Physiological Parameters in Patients With Atopic Dermatitis and Healthy Persons

The study was performed to investigate the effects of a probiotic supplementation containing Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 and Bifidobacterium animalis subsp. lactis DGCC 420 (B. lactis 420) on clinical, immunological and faecal parameters in healthy volunteers and in patients with atopic dermatitis (AD).

研究概览

地位

完全的

详细说明

Recent studies suggest that oral bacteriotheraphy with probiotic bacteria might be useful to alleviate atopic dermatitis in infants. There are few indications about the effect of probiotics in the management of atopic dermatitis in adults.

As a precondition for participating in this study, the subjects were provided information in writing and verbally about the details of the study. Informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination in the Clinic for Dermatology and Dermatologic Allergology of the Friedrich Schiller University Jena. The AD was diagnosed according to the atopy-score of Diepgen. Severity of eczema was evaluated by using the SCORAD score. A skin prick test was performed for the exclusion of type 1 sensitivity to cow's milk.

The study was designed as a placebo-controlled and cross-over study. After a 3-week run-in period the 30 participants (15 healthy subjects and 15 patients with AD) were randomized to receive either 200 ml/d of a probiotic drink containing L. paracasei Lpc-37, L. acidophilus 74-2 and B. lactis 420 or 200 ml/d of a placebo drink for 8 weeks. After a 2-week washout period the intervention was crossed between the groups and the respective products were consumed for another 8 weeks followed by a 2-week washout period. Venous blood and fresh stool samples were collected before the beginning and at the end of each period. In AD patients the Scoring of atopic dermatitis (SCORAD) was assessed by the same physician every 4 weeks and 2 weeks after the wash-out period, respectively.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Thuringia
      • Jena、Thuringia、德国、07743
        • University of Jena, Institute of Nutrition, Department of Nutritional Physiology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Healthy subjects:

  • No allergic asthma
  • No allergic rhinoconjunctivitis
  • No food allergies
  • Exclusion of atopic diathesis (< 7 points in Erlangen atopy score)

Patients with AD:

  • Clear diagnosis of atopic dermatitis (> 10 points in the Erlangen atopy score) or flexural eczema or pruritis for at least 12 months (recidivating or permanent)
  • SCORAD 5-30 (minor or medium AD)
  • Willingness to apply for the duration of the study exclusively the cosmetic products recommended by the accompanying doctor and to use the recommended class II corticosteroid (Advantan) as further therapy of AD (for example during an episode)

Exclusion Criteria:

  • Pregnancy, lactation
  • Immune suppressive or cytostatic therapy or systemic steroids < 1 month before the first intake
  • Phototherapy or systemic therapy of AD < 1 month before the first intake
  • Active infections of the skin
  • Relevant asthma disease, which must be treated with inhalative corticoids (FEV1 < 70 %)
  • Patients with an indigestibility of/allergy against the components of milk/lactose intolerance (previously known or detected in the allergy test)
  • Patients under long-term treatment with systemic steroids, depot steroids, long-acting antihistamines, tranquilizers, psychopharmaceuticals
  • Intake of antihistamines, psychopharmaceuticals with antihistaminic effect and application of steroid containing cream to the forearms within the past 7 days before prick testing resp. treatment of the patient with Astemizol (Hismanal) within 4 weeks before the test. Such patients must be excluded from the study because of the long half-life of the medicament.
  • Acute or chronic symptomatic heart disease or severe internistic diseases
  • Autoimmune diseases, immune deficiencies (including immune suppressive treatment)
  • Immune-complex-induced immunopathies or malignant tumors
  • Abuse of alcohol, drugs or medicaments

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Probiotic
intervention
Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp. lactis DGCC 420

研究衡量的是什么?

主要结果指标

结果测量
大体时间
SCORAD change in patients with AD taken at baseline and after 4 and 8 weeks, respectively -change in phagocytic and oxidative burst activity of monocytes and granulocytes at baseline and after 8 weeks
大体时间:8 weeks
8 weeks

次要结果测量

结果测量
大体时间
cellular and humoral immunological parameters (CD's; Interleukins); detection of bacterial species in faecs, faecal short-chain fatty acids, blood lipids
大体时间:8 weeks
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gerhard Jahreis, Prof. Dr.、University of Jena, Dept. of Nutritional Physiology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年12月1日

初级完成 (实际的)

2005年7月1日

研究完成 (实际的)

2005年7月1日

研究注册日期

首次提交

2007年10月25日

首先提交符合 QC 标准的

2007年10月25日

首次发布 (估计)

2007年10月29日

研究记录更新

最后更新发布 (估计)

2008年4月15日

上次提交的符合 QC 标准的更新

2008年4月10日

最后验证

2008年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅