The Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis
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
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Thuringia
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Jena, Thuringia, Alemania, 07743
- University of Jena, Institute of Nutrition, Department of Nutritional Physiology
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Probiotic
intervention
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Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp.
lactis DGCC 420
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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
Periodo de tiempo: 8 weeks
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8 weeks
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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cellular and humoral immunological parameters (CD's; Interleukins); detection of bacterial species in faecs, faecal short-chain fatty acids, blood lipids
Periodo de tiempo: 8 weeks
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Gerhard Jahreis, Prof. Dr., University of Jena, Dept. of Nutritional Physiology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- LSEP H18-05
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