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

University of Jena

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Dietary Supplement: probiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT00550472

LSEP H18-05

Details and patient eligibility

About

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).

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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