Atopic Dermatitis Clinical Trial
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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