The Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis - Full Text View

Sponsored by:	University of Jena
Information provided by:	University of Jena
ClinicalTrials.gov Identifier:	NCT00550472

Purpose

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).

Condition	Intervention
Atopic Dermatitis	Dietary Supplement: probiotics

Drug Information available for: Lactobacillus acidophilus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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

Further study details as provided by University of Jena:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	December 2004
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Probiotic: Experimental intervention	Dietary Supplement: probiotics Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp. lactis DGCC 420

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550472

Locations

Germany, Thuringia
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743

Sponsors and Collaborators

University of Jena

Investigators

Principal Investigator:

Gerhard Jahreis, Prof. Dr.

University of Jena, Dept. of Nutritional Physiology

More Information

Responsible Party:	Dept. of Nutritional Physiology ( University of Jena )
Study ID Numbers:	LSEP H18-05
Study First Received:	October 25, 2007
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00550472
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Jena:

probiotics
atopic dermatitis
immune system
human

Lactobacillus
Bifidobacterium
healthy subjects

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Healthy
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009