The Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT00550472|
Recruitment Status : Completed
First Posted : October 29, 2007
Last Update Posted : April 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Dietary Supplement: probiotics||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
Dietary Supplement: probiotics
Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp. lactis DGCC 420
- 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 [ Time Frame: 8 weeks ]
- cellular and humoral immunological parameters (CD's; Interleukins); detection of bacterial species in faecs, faecal short-chain fatty acids, blood lipids [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550472
|University of Jena, Institute of Nutrition, Department of Nutritional Physiology|
|Jena, Thuringia, Germany, 07743|
|Principal Investigator:||Gerhard Jahreis, Prof. Dr.||University of Jena, Dept. of Nutritional Physiology|